Podcasts by Medical Device made Easy Podcast

What is Usability for Medical Devices?  from 2023-12-12T00:00

The usability is a term that seems complicated but within this episode Michael Engler we will try to explain to you in simple terms how you can succeed within your project. So don’t miss this ep...

Medical Device News: December 2023 Regulatory Update from 2023-12-05T00:00

This is the last Medical Device News of 2023 so I hope this will contain all information needed. Enjoy your Regulatory Update!

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What is the situation regarding digitalization in Medtech? from 2023-11-28T08:10:01

During the MEDXD in Berlin, we had a panel discussion on digitalization. Monir El Azzouzi was moderating it with some expert in Medical Device digitalization topics.

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How to find your Predicate Device for your 510K Submission? from 2023-11-21T00:00

In this episode, Beat Keller from imt will be helping us to understand the secrets of Predicate Devices. This is specific to the US Market, but we will also make few parallels with the EU as we ...

How to CE certify a Calculator, Risk Score…?  from 2023-11-14T00:00

In this episode, Cesare Magri will help us understand how API can be considered as a Medical Device. Some calculators are existing and also used as API. So should those API developers create a Q...

Medical Device News – November 2023 Regulatory Update from 2023-11-09T00:00

This episode will be your Update of what happened within the Medical Device community. Check the show notes for all the links. Use these updates also for your QMS Regulatory updates so don’t hes...

Validate your Iphone, Samsung Galaxy, Huawei… for your Software from 2023-10-31T00:00

MDCG 2023-4 was released and this raised a lot of questions or concerns. If you are using a software and for the functioning of it you need sensors or cameras from a third party device like a sm...

Afrisummit 2023 Interviews Part 2 – Egypt Situation  from 2023-10-24T00:00

This is part 2 of the interviews made at Afrisummit. I was able to interview some key stakeholders. I am sharing with you these interviews and I hope this will help you understand the situation ...

Afrisummit 2023 Interviews Part 1 from 2023-10-17T00:00

When I was at the Afrisummit I was able to interview some key stakeholders. I am sharing with you these interviews and I hope this will help you understand the situation in Middle East and Afric...

What are some pitfalls to avoid during Software Design? from 2023-10-10T00:00

When we develop a Software, there are some pitfalls that you can avoid. Weronika Michaluk from HTD Health will explain to us how to do that. Don’t miss this to accelerate your development and av...

October 2023 Regulatory Update from 2023-10-04T00:00

MEDICAL DEVICE NEWS October 2023 Regulatory Update

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What is the EUDAMED Updates? from 2023-09-26T00:00

In this episode, Richard Houlihan will explain to us the current situation about EUDAMED. This is the new European Database for Medical Devices and a lot of people are asking to start the regist...

Interviews on Being The PRRC (Part 2) from 2023-09-19T00:00

In this second part of this podcast series on Team-Prrc interviews. we have 3 additional guests. Don’t miss the first one where we also got great interviews. In this episode, […]

Interviews on Being The PRRC from 2023-09-13T00:00

Within this video you will see 4 interviews on the PRRC role. First one with Piero Costa where we will talk about the role of a PRRC within the different […]

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MEDICAL DEVICE NEWS – SEPTEMBER 2023 Regulatory Update from 2023-09-06T07:51:27

This month we will review all what happened in the Medical Device world during the last weeks and what will happen in the next weeks. Check that

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How to perform your Cleaning Validation in practice? from 2023-08-29T00:00

If your Medical Device needs to be cleaned then it means that you need to prove that the cleaning method you propose is working. So how to do that? A laboratory can help for this by testing your...

What are the Acceptance Criteria for your Clinical Evaluation? from 2023-08-22T01:07:20

We all want to follow EU MDR 2017/745 but for that you need to have clinical data and a clinical evaluation. But what are the acceptance criteria for it? Who defines the rules? Can this evolve? ...

Why you should automate your Software validation? from 2023-08-15T00:00

Did you had this blank in your head when an auditor asked you the validation documents of your software? I know your pain. So today we will try to help you validate your software with some autom...

Hire your QA RA person with no Budget  from 2023-08-08T08:02:40

We feel your pain when your bosses ask you to hire a QA RA person, but the challenge is that there is no Budget for it. But you want to impress them, so what to do. In this episode Mitch Robbins...

Who should be on your Risk Management Dream Team?   from 2023-08-01T00:00

Everyone is talking about Risk Management file and ask you to provide that to them. But should you do that alone or identify the best partners on your team to be successful. This is what Naveen ...

Artificial Intelligence in the Medical Device Industry from 2023-07-25T00:00

There is still this misunderstanding about AI, and we wanted to discuss about AI for Medical Devices to really understand what this is. I have invited Christophe Girardey from Wega to put some l...

Validation of Quality Software in Medical Devices  from 2023-07-18T00:00

Software validation when used on patient is common and mandatory. But now when we tell you that you should validate also the software you are using to record your documents, CAPAs, or work on th...

How to register Medical Devices in Saudi Arabia? from 2023-07-11T01:00

Saudi Arabia is a major actor in the Medical Device world. A lot of companies are willing to enter this market that can help them to reach also other regions of the Middle East. We will discuss ...

Medical Device News – July 2023 Regulatory Update from 2023-07-04T08:15:26

july 2023regulatory update

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What should you know on UKCA extension from 2023-06-27T00:01

UK decided to add more time to implement the UKCA. Apparently, the EU amendment to extend the EU MDR and IVDR was also something they looked at to define their timeline. So, let’s see what will ...

How to connect Software dev and QA RA Team   from 2023-06-20T00:00

You may be on the business of Software development and you ask yourself why your Dev team is not really happy to work with Quality and Regulatory affairs team? In this episode, we will discuss w...

The great misunderstanding of EU MDR amendments from 2023-06-13T00:00

Since the EU MDR extension was voted, there are still a lot of questions remaining. This is what we will try to clarify today with Florian Tolkmitt from Pro-Liance. This podcast will provide you...

Medical Device News -June 2023 regulatory update from 2023-06-08T00:00

Medical Device News - june 2023 regulatory update

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How to master Regulatory Intelligence? from 2023-05-30T00:00

We all need to keep ourselves up to date. But how to access reliable information and how often should a check be done. This is what we will discuss with Ivan Perez Chamorro from MedBoard. You wi...

What if your Medical Device Company goes Bankrupt? from 2023-05-23T00:00

I know this is not really something that people anticipate. But the EU MDR is asking you to anticipate that. So don’t miss this as this can raise a Non-Conformance from the Notified Body during ...

Technical Files Inconsistencies Identified by Notified Bodies from 2023-05-16T00:00

Technical Files inconsistency, it is when your technical file is not providing the right information or that all the information is not aligned. Here we will try to look at some of these issues....

The truth about the UK vs EU situation from 2023-05-09T00:23:15

We hear so many things about UK and the timeline and now that EU issued an extension, the question is “Does this change something for UK” So on this episode we’ll review again what are the requi...

Medical Device news – May 2023 Regulatory Update from 2023-05-05T01:00

Medical Device news - May 2023 Regulatory Update- easy medical device

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Transition to Agile for Software as Medical Device  from 2023-04-25T01:00

We start to talk more and more of Software as Medical Device or SaMD. This time we will check with you how to develop a Software and transition to the Agile methodology with the company IronRoos...

Prepare your audit like a PRO from 2023-04-18T00:00

If you are selling a Medical Device that is not a class I, then you know that you have to go through an audit with a Notified Body. So let’s discuss how you should be prepared for that with Kara...

What is a SOUP for your Software Development? from 2023-04-11T01:00

In this context SOUP is not a dish but Software Of Unknown Provenance which is the term used for Software that was not created by you. Christian Kaestner from Medical Device HQ will explain to u...

Medical Device News – March 2023 Regulatory Update from 2023-04-04T02:00

► Medboard platform: https://www.medboard.com/ ► Podcast page: https: //podcast.easymedicaldevice.com/226-2/ ► MEDBOARD SHOW NOTES LINKS:​​​​ https://www.medboard.com/reports/easy-medical-device...

How to perform Risk Management for a Software ? from 2023-03-28T00:00

In this episode, Bijan Elahi will help us perform risk management for SaMD and give us some tips on the best strategies. Bijan is also the author of the book […]

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How to create a Proactive Postmarketing Surveillance? [EU MDR] from 2023-03-21T00:00

The postmarketing surveillance is a major process within the EU MDR. Today Marcus Emne from Hoodin will explain to us how this is working and how the Artificial intelligence may help.

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What you should know about Vigilance Reporting for Medical Devices? from 2023-03-14T00:00

Vigilance Reporting is one of the process that everyone should have but that no one wants to use. So this is really difficult to understand all the requirements to it. Also knowing that this may...

The Step-by-Step recipe to get MDR& IVDR Certified from 2021-12-20T18:00

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Which devices cannot be Custom-made? [Erik Vollebregt] from 2021-12-13T16:00

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Medical Device News: December 2021 Regulatory Update from 2021-12-06T18:00

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Let’s unleash “MDR Classification surprises” [MDR 2017/745] from 2021-11-30T02:00

The MDR classification was hidding some surprises and I have asked Frank Matzek from Biotronik to tell us more about the products and rules we need to take care of. So Enjoy! The post Let’s ...

Let’s unleash"MDR Classification surprises” [MDR 2017/745] from 2021-11-29T18:00

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How to approach your Notified Bodies? [Dr. Royth von Hahn – TÜV SÜD] from 2021-11-22T18:00

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Is it possible to Private Label a Medical Device under MDR & IVDR? from 2021-11-16T02:18

OEM OBL is really used a lot by Medical Device Manufacturers. But this is not possible anymore with EU MDR. So please listen to that as maybe you are doing it without knowing. The post Is it possi...

Is it possible to Private Label a Medical Device under MDR& IVDR? from 2021-11-15T18:18

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How to improve your QA RA Communication with Lesley Worthington? from 2021-11-08T18:00

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Medical Device News – November 2021 latest update from 2021-11-01T20:00

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How does the EU Commission plan to save IVDR 2017/746? from 2021-10-25T18:20

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How to comply with MDR when products contain CMR Substances? from 2021-10-18T19:00

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EUDAMED Update: Should you register your medical devices now? from 2021-10-11T19:00

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Medical Device News – October 2021 Regulatory Update from 2021-10-04T19:30

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Why does an Importer/Distributor need to appoint a Notified Body? from 2021-09-27T17:00

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How to collect Clinical Data within the 21st Century [Jon Bergsteinsson] from 2021-09-20T18:00

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How to manage the IVDR transition period? [IVDR 2017/745] from 2021-09-13T17:00

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Is it a good idea to sue my Notified Body? [Erik Vollebregt] from 2021-09-06T17:00

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Medical Device News – September 2021 Latest Updates from 2021-08-30T17:00

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How to Certify a Software as Medical Device? (Dr. Abtin Rad – TÜV SÜD) from 2021-08-23T17:00

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Better to be a Consultant or a Full-time employee? [Lifescience industry] from 2021-08-16T17:00

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What can we learn from the first MDR audits? [Martin Witte -TÜV SÜD] from 2021-08-09T17:00

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Medical Device News – August 2021 Regulatory Update [MDR & IVDR] from 2021-08-03T00:00

This is already Mi-Year with the summer holiday. But EU Commission didn't sleep as there was a lot of MDCG guidance released. Let's review the agenda for this month and don't miss all the links. T...

How to implement Vigilance Reporting for MDR and IVDR? from 2021-07-27T00:00

Vigilance Reporting is an important system to have within your quality management system. Even if you are still MDD, you need to comply to the MDR requirements for it. So I will help you for that....

System and Procedure Pack the RETURN with Erik Vollebregt from 2021-07-20T00:00

After receiving a lot of questions on System and Procedure pack we have decided to have a second episode on it with Erik Vollebregt. So let's review some special cases and also some feedback from ...

How to interpret the first Expert Panel Opinion? [Bassil Akra] from 2021-07-13T00:00

Bassil Akra will help use interpret this first Expert Panel Opinion. Bassil already helped on a previous episode where we discussed about the creation of this Expert Panel. Let's review this first...

Medical Device News: The July 2021 Update [MDR IVDR FDA SFDA] from 2021-07-06T00:00

We will update you on all what happened within the Medical Device regulation. All new The post Medical Device News: The July 2021 Update [MDR IVDR FDA SFDA] appeared first on Medical Device made E...

How to build your State-of-the-art for your Medical Devices? from 2021-06-29T00:00

The State-of-the Art is one of the component that can make you win or make you lose. If this research is not done correctly, it can ruin your Clinical Evaluation Report or Performance Evaluation R...

How Intellectual Property is linked to the Medical Device Regulation? from 2021-06-22T00:00

In the case you are placing your brand trademark on a product, or if you buy a product designed by another company... then you need to understand the rules related to Intellectual properties. This...

How to perform a good Clinical Investigation with Helene Quie from 2021-06-15T00:00

Clinical Investigation is not really an easy process. So it can be important for your to understand what are the requirements and get some details about time and cost. Helene Quie from Qmed Consul...

How to perform a Biological Evaluation for your Medical Device? from 2021-06-08T00:00

This podcast episode is really important as this answers some of the questions that a lot of my customers are asking. So I hope this will help you to understand why this is important to perform a ...

Medical Device News – June 2021 Update [EU MDR Date of Application] from 2021-06-01T00:00

Medical Device News June 2021 Update is providing you all the last updates. This IS the episode of the EU MDR date of application. A lot of news provided. The post Medical Device News – June...

EU MDR Survey: What is the Industry’s opinion? [Catherine Higginson] from 2021-05-25T00:00

EU MDR is starting tomorrow and we wanted to check the situation for Economic Operators. We had already interviewed Catherine on the previous survey release. This time we do a follow-up The post E...

MDR is coming so brace yourself with Erik Vollebregt from 2021-05-18T00:00

1 week to the EU MDR and we hope that you are ready. If not, then you can maybe listen to this episode as we are answering some last minute questions. The post MDR is coming so brace yourself with...

FDA: Is the Emergency Use Authorization worth it? (EUA) from 2021-05-11T01:00

This process called EUA was really famous last year when everyone wanted to register its face mask or respirator or covid-19 test in the USA. After 1 year let's see the conclusion of Michelle Lott...

Medical Device News – May 2021 Update [EU MDR 2017/745] from 2021-05-04T00:00

This is the last month before the EU MDR 2017/745 Date of Application. We will talk about that and about all the updates The post Medical Device News – May 2021 Update [EU MDR 2017/745] appe...

Checklist – What is important before the EU MDR Date of Application? from 2021-04-27T00:00

It is Day -30 for the EU MDR date of application. So let's summarize what should be ready for you and also what is not mandatory. The post Checklist – What is important before the EU MDR Dat...

How to perform correctly a Merger & Acquisition during the MDR transition? from 2021-04-20T00:00

Merger and Acquisition is an important topic to understand as people think this is a fiance activity. But when you'll listen to this episode, you will not think that anymore. The post How to perfo...

How to write your Performance Evaluation? [IVDR 2017/746] from 2021-04-13T00:00

In this episode Hakan Inan will help us to write our Performance Evaluation specifically for IVD products.

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Medical Device News – April 2021 Update [EU MDR & IVDR] from 2021-04-06T00:00

In this episode, we will summaries what happened for the Medical Device Community. We will explain to you the last MDCG Guidances that were issued and the Notified Bodiy Situation.

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Will it be really difficult for IVD manufacturers? [IVDR 2017/746] from 2021-03-30T00:00

IVDR is planned for May 26th, 2022 but why it will be more difficult for IVD manufacturers than for MDR manufacturers? Listen to this episode to have a better understanding The post Will it be rea...

How to create a Label under MDR? (Questions & Answers) from 2021-03-23T00:00

During the Greenlight Guru summit on EU MDR & IVDR I have presented the way to create a label. And following the session there was so many questions that I decided to answer to some of them w...

How System and Procedure Pack are regulated under EU MDR? from 2021-03-16T00:00

The system and procedure pack within EU MDR is still a mystery for a lot of people and Erik Vollebregt accepted to help us have a better understanding of this specific cases. We will explain to yo...

How to import your Medical Devices with an Independent Importer? from 2021-03-09T00:00

In this episode, Edgar Kasteel will help us understand the role of an importer and will also tell us more about the model of independent importers. The post How to import your Medical Devices with...

What is the Medical Device News? [March 2021 update] from 2021-03-02T00:00

In this monthly episode we will review what happened within the Medical Device industry. EUDAMED, Covid19, Notified Bodies... The post What is the Medical Device News? [March 2021 update] appeared...

The best design methods for successful development? [Jon Speer] from 2021-02-23T00:00

Waterfall or Agile? Jon Speer from Greenlight Guru will help to understand what is the best methodology that can be used to develop your medicaldevices. The post The best design methods for succes...

How to find a QA RA job for Medical Devices? [Karandeep Badwal] from 2021-02-16T00:00

How to find a job in the QA RA world for Medical Devices? This is what we will discuss with Karandeep Badwal. We will provide our tips and also the platforms to visit. The post How to find a QA RA...

What is the QA RA Mindset with Michelle Lott from 2021-02-09T00:00

If you are thinking that you are the only one that has issues as QA RA, then listen to this episode. I hope this will help you to understand that there is a certain mindset to have when you do thi...

February 2021 Update – Medical Devices Remote Audit by the EU from 2021-02-02T00:00

On this podcast episode, we'll perform the February 2021 update. What happened in the Medical Device World. One of the HOT TOPICS is the Remote audit authorization by the EU Commission but we'll s...

How to perform your PMS more easily with Ivan Perez Chamorro? from 2021-01-26T00:00

PMS is an action that take some hours to perform. But with all the information generated, it get worse and worse. So I have invited Ivan Perez Chamorro, the Founder and CEO of Medboard to help us ...

How to get the MDR certification for Artificial Intelligence Softwares? from 2021-01-19T00:00

The new EU MDR is now taking into account dangerous Software as a Medical Device SAMD. In this episode we will talk specifically about Artificial Intelligence Software. How to make them safe and e...

How to register a Medical Device in Israel? (Liat Nadel) from 2021-01-12T00:00

Liat Nadel is the CEO of L.S. Marketing & Registration. She will help us to understand the context for the registration of Medical Devices in Israel. The post How to register a Medical Device...

Medical Device News – January 2021 Update (Monir El Azzouzi) from 2021-01-05T09:00

In this first episode of 2021 we provide you an update of the Medical Device Regulation situation. We will talk about Brexit, Swixit, Turkxit, MDCG, Notified Bodies, Approved Bodies, Trainings, Po...

How Easy Medical Device can help you? (Monir El Azzouzi) from 2020-12-28T00:00

This is the last episode of 2020 and I wanted to share with you the progress of the Easy Medical Device project. I will also tell you the next steps that I will try to achieve. Let me know how I c...

How to deal with Significant Changes within MDR & IVDR with Martin Witte from 2020-12-21T00:00

Martin Witte from TÜV SÜD will help us to understand the significant changes to your devices and the consequence of it for your CE Certificate. You will have to listen carefully if you are selling...

How to register a Medical Device in Mexico? [Josué Garza] from 2020-12-14T00:00

You maybe know how to register your devices in Europe or USA now. But let's discover how we can do that in Mexico with Josué Garza from IPS or Insumos para la salud. You'll learn the 3 pathways to...

Medical Device News: What happened in November 2020? from 2020-12-07T00:00

This November update is providing a lot of information on what you should not miss. We will talk Brexit, Eudamed, Jobs, Training... A lot of topic to help you stay up-to-date. The post Medical Dev...

Is it Easy for a Notified Body to get EU MDR accredited? from 2020-11-30T00:00

In this episode, we will hear the journey of a Notified Body to get EU MDR accredited. We hope this will help you to understand how difficult it is and why you should be patient with your Notified...

How a Quality & Regulatory training can help you? [Sofmedica] from 2020-11-23T00:00

In this episode, we will tell you why this is important to invest on trainings for your employees. I have invited a company that participated to the Green Belt Certificate and I asked them to tell...

Do you need an Expert Panel for your Medical Devices? [Bassil Akra] from 2020-11-16T00:00

If you thought that clinical evaluation was already difficult to work on with the new EU MDR, then listen to this episode where we will tell you about the new level of difficulty that is coming so...

What are Common Specifications under EU MDR & IVDR? from 2020-11-09T00:00

Common Specifications are a type of regulation that we will explain to you in this episode with Stefan Bolleininger. The one on Reusable single use device was published. We expect more to come. Th...

We’ve reached episode 100 – What happened for the last 2 years? from 2020-11-02T00:00

We have reached 100 episodes on the podcast and today we will celebrate that. Here is an episode with some of the great influencers in the Medical Device field which are sharing with us their jour...

How to certify a self-testing device under IVDR? [Erik Vollebregt] from 2020-10-26T00:00

Self-testing devices are already existing in the market and already mentioned under IVDD. But what does change with the new IVDR? Erik Vollebregt from Axon Lawyers will help us to interpret that. ...

What is the cost of EU MDR 2017/745? [Catherine Higginson] from 2020-10-19T00:00

EU MDR is a new regulation and if you have not started a project like that you need to understand that it is costing. Not only money but time, resource... So listen to this episode if you want to ...

How to register your Medical Device in the ASEAN region? from 2020-10-12T00:00

Michael Wetherington will by your instructor in this episode. He will provide you all the information to register your product in the ASEAN region. This is the countries located in the South East ...

The latest news on Brexit, Swixit and EU MDR [Medical Device News] from 2020-10-05T00:00

This month a lot of exists on the Medical Device news. We are still under a pandemic so conferences are going virtual and Easy Medical Devices has the best training for EU MDR. The post The latest...

How to register ATMP-Device combination products? from 2020-09-28T00:00

ATMP is a category of product not so well known by the regulatory affairs professionals. I wanted to help you understand how they are working with Margareth Jorvid. She will provide us with a spec...

How to get some help from Medical Device Regulators with Cliff Bleustein from 2020-09-21T00:00

In this case study we will see how Apos Therapy was able to register his product in the US for certain therapy. Cliff Bleustein; President and CEO of Apos Therapy is my guest today and you'll see ...

How can GDPR impact Medical Devices with Erik Vollebregt from 2020-09-14T00:00

GDPR is not specific to medical devices, but any judgment that is issued can impact devices. And this is the case with the SHREMS II case. Erik Vollebregt accepted to answer my questions on this t...

Be successful at your MDR and IVDR audit with Martin Witte from 2020-09-07T00:00

The audit for a Medical Device company can be a real struggle if this was not correctly prepared. If you want to understand what a Notified Body is looking for when it is coming to your company, t...

Medical Device News – August 2020 Review (Monir El Azzouzi) from 2020-08-31T00:00

In this episode we will talk about the UDI FAQ, the new regulation for reprocessing of single use devices, the EUDAMED actor module, the new Guidances released... A lot to discuss today. The post ...

How to switch quickly to a Virtual Conference with TOPRA from 2020-08-24T00:00

Kevin Pay and Raluca Radu from TOPRA are helping us to understand how a virtual conference can bring the same type of experience as a normal one. This year the TOPRA Symposium will be virtual so y...

Best practice for Device Testing with Michael Wetherington from 2020-08-17T00:00

Medical Device Testing is something all medical device manufacturers should perform. How can you prove that your device is safe and performing without that. So now how to do it? Michael Wetheringt...

Best overview of IEC 60601 for Medical Device electrical equipment from 2020-08-10T00:00

IEC 60601 is one of the most important standard to look at if you have an electrical medical devices. In this episode Leonard Eisner also called the IEC 60601 guy will help us understand the full ...

Medical Device News – July 2020 Update on Quality and Regulatory for Medical Devices from 2020-08-03T00:00

In this monthly update we will review some hot topics that happened within the last weeks., the Notified Body Situation, the Guidance and standards update and finally what happened at Easy Medical...

Learn UDI code for Medical Devices with Sylvia Reingardt from 2020-07-27T00:00

UDI is new for Europe but already exist in the USA. We will explain to you what is important to understand for the EU version as there are some differences. Sylvia Reingardt from GS1 will be my gu...

Understand IEC 62304 for Medical Device Software with Adnan Ashfaq from 2020-07-20T00:00

What is IEC 62304? This is the question I asked Adnan Ashfaq from Pharmi Med Ltd. The answer is helping a lot to understand the interaction with other standards and regulations. Enjoy it! The post...

How to become a PRRC with TEAM-PRRC (EU MDR & IVDR) from 2020-07-13T00:00

Team-PRRC is invited to this episode to help us understand how to become a PRRC. This is a new role required for Medical Device manufacturers. In this episode, we will also share with you what TEA...

Medical Device News – June 2020 Update from 2020-07-06T00:00

During this update, we will talk about the Coronavirus situation, the Notified Body accredited, the CEN CENELEC mandate for Harmonized Standards, the Green Belt Certification Program. A lot to say...

The secrets to being EU MDR certified with Shokoufeh Khodabandeh from 2020-06-29T00:00

Shokoufeh from Straumann in Switzerland is sharing with us her journey on the EU MDR world. She will tell us what helped the team to reach this success and what she would have changed. The post Th...

How to perform your Process Validation with Adnan Ashfaq (IQ OQ PQ) from 2020-06-22T00:00

Process Validation is an important but difficult topic. You should not only be good at engineering but also at explaining to your staff. Because a good validation worth nothing if the Staff is not...

How to execute your Internal Audits? (Medical Device companies) from 2020-06-15T00:00

In this episode, I will help you understand the power of Internal Audits. Some of you are using that just because ISO is requiring it but you can get so much out of it. The post How to execute you...

Medical Device News – May 2020 Review with Monir El Azzouzi from 2020-06-08T00:00

The Month of May 2020 was supposed to be the beginning of the EU MDR. This was not as the new date is on May 26th, 2021. We will celebrate the Non-Anniversary of it and also talk about IVDR, MDCG,...

What means Sufficient Clinical Data with Bassil Akra (EU MDR) from 2020-06-01T00:00

Sufficient Clinical Data is a new vocabulary introduced with the EU MDR 2017/745 but this is still unclear what is sufficient and what is too weak. Bassil Akra from QUNIQUE Group will explain to y...

What is the Notified Body situation? (Bassil Akra from TUV SUD) from 2020-05-25T00:00

If you are looking for a Notified Body for your Medical Device, you maybe have some difficulties to find one. In this episode, Bassil Akra from TÜV SÜD will explain to you the reason of this. The ...

How to get ISO 13485 certified? (Quality Management System) from 2020-05-18T00:00

I'll answer one of the most frequently asked question I receive from my followers. How to get ISO 13485 certified? Don't miss the links on the show notes to get more material to read. The post How...

How to get your Digital Health Application reimbursed in Germany? (DIGA) from 2020-05-11T00:00

You are maybe a Digital Health Application developer, so this podcast will be of a great interest for you. If you don't place to make your device available in germany, than DIGA may help you chang...

Medical Device News – April 2020 Regulatory Update from 2020-05-04T00:00

Medical Device News April 2020- We will talk about how Coronavirus is shaking the Medical Device World, the Notified Body Situation, the MDCG guidances and the Easy Medical Device events. Enjoy! T...

How to calculate your sample size with Jon Bergsteinsson from 2020-04-27T00:00

Don't worry, we will not show you any equation for calculating the sample size. But we will show you how to do it and why you should be careful on some important parameters. Then you can see some ...

The 1-year delay for the EU MDR 2017/745 with Erik Vollebregt from 2020-04-20T00:00

This week there was an important vote regarding the proposal to delay the EU MDR until May 26, 2021. The parliament adopted it and we wait for the publication on the official journal. But what wil...

Medical Device School – Why are Staff hiding problems to QA & RA? from 2020-04-15T00:00

If you are not working in QA RA you maybe don't understand this. But sometime people don't want to follow the process not because they want to annoy you but because they are afraid of some consequ...

MDR & Drug-Device Combination Products with Theresa Jeary from 2020-04-13T00:00

Did you know that the EU MDR is amending 2001/83/EC for Medicinal Products. This may have some consequences for your products if it involves a Drug-Device combination. Monir El Azzouzi and Theresa...

Medical Device News – March 2020 Review (EU MDR) from 2020-04-06T00:00

The month of March 2020 is over but there was a lot of information provided regarding the Medical Device industry so let's listen to the different news with Monir El Azzouzi The post Medical Devic...

What is a Significant Change for your Medical Device? with Erik Vollebregt from 2020-03-30T00:00

This is an important question if you understand the rule for a transition period of your device under EU MDR article 120(3). If you perform a significant change then you may be prepared for the co...

All about Class Is, Im and Ir with Elem Ayne (EU MDR 2017/745) from 2020-03-23T00:00

In this episode we will focus specifically on Medical Device class I that are "Sterile", with measuring function" or "Reusable surgical instruments". Elem Ayne will help us to understand what you ...

Cybersecurity for your Medical Devices with Erik Vollebregt from 2020-03-16T00:00

Do you recall those movies with hackers that are taking the control of an hospital or of your pacemaker. Is this Science Fiction or reality. On this episode, Monir and Erik will explain to you how...

Medical Device Regulatory Update – February 2020 from 2020-03-09T00:00

In this episode, we will talk about, Coronavirus, MDCG, Notified Body, US guidance, Podcast episodes, LinkedIn Live... So don't miss it. The post Medical Device Regulatory Update – February ...

Do your Economic Operators need a Quality Management System? from 2020-03-04T00:00:32

It is clear that a Manufacture of a Medical Device need to have a Quality Management System. But what is the answer for an importer, Distributor or Authorized Representative? You'll hear it on thi...

Create your intended purpose with Cesare Magri (Medical Device) from 2020-03-02T00:00

The intended purpose of your device is critical but a lot of manufacturers are nor really putting much effort to write a good one. Check on this episode with Cesare Magri why this is important and...

Medical Device School: What should verify your Economic Operators? from 2020-02-26T00:00

Your Economic Operators do have some responsibility per EU MDR and IVDR. What should they check? Monir El Azzouzi and Erik Vollebregt will help you understand that on this bonus episode. The post ...

Clinical Data for Low Risk Medical Devices with Robert van Boxtel from 2020-02-24T00:00

Many medical device manufacturers try to solve a puzzle regarding their Low risk medical devices. How to write Clinical Evaluation for it without data? here is the solution. Download the presentat...

Medical Device School – Who controls your Economic Operators? from 2020-02-19T00:00

In this episode we will explain you the way that Economic Operators are controlled. This may seem obvious but the answer can be different per Economic Operator. So listen to this short episode of ...

Are Brexit, Swixit, and Turkxit a reality? with Erik Vollebregt from 2020-02-17T00:00

Brexit, Swixit, Turkxit. These are the topics of this episode of the Podcast. We will try to help you understand all these -XIT and what is the impact to Medical Device manufacturers. The post Are...

Medical Device School – Who are your Economic Operators? from 2020-02-12T00:00

Who are the Economic Operators mentioned on the MDR and IVDR? This is the question that Monir El Azzouzi and Erik Vollebregt will try to answer. The post Medical Device School – Who are your...

Swixit or not Swixit? this is the question with Ronald Boumans from 2020-02-10T00:00

Swixit or not Swixit? is an alert to Medical Device Manufacturers regarding the political game that is played between Europe and Switzerland. Let's see the impact for the Swiss market but also for...

Medical Device School – Process Validation or Verification? from 2020-02-05T00:00

Process Validation or Verification? Some people are mixing both concepts, this is why Monir and Stefan will help you understand when to use one or the other. The post Medical Device School –...

Episode 61 – Medical Device Regulatory Update: January 2020 from 2020-02-03T00:00

This episode will be dedicated to provide the regulatory updates that happened on January 2020. This will help you to stay up-to-date. The post Episode 61 – Medical Device Regulatory Update:...

How to register your Device in Brazil with Tania Aprigliano? (ANVISA) from 2020-01-27T00:00

As Tania is saying this is the best time to export your products to Brazil, so we'll teach you how to register your products there. Enjoy! The post How to register your Device in Brazil with Tania...

Why is it Awesome to work in a Quality or Regulatory affairs job? from 2020-01-22T00:00

Quality and Regulatory affairs is not really a job that everyone want to work in. But this is maybe you didn't listen to the right arguments. Check what Monir El Azzouzi and Karandeep Badwal want ...

How to create a QMS compliant to MDR with Stefan Bolleininger from 2020-01-20T00:00

MDR is requiring to create a Quality Management System but how to do that. This is what you will learn with Monir El Azzouzi and Stefan Bolleininger. The post How to create a QMS compliant to MDR ...

How to register your Medical Device through 510k with Michelle Lott from 2020-01-13T00:00

Michelle Lott is my guest and will help us understand the 510k registration process with the US FDA. Should you use it? Is this changing? Learn everything in 1 episode. The post How to register yo...

Medical Device School: How to audit your Suppliers? from 2020-01-08T00:00

How should you audit your suppliers? Should you do the same as a Notified Body? Monir El Azzouzi and Stefan Bolleininger are providing you their opinion. The post Medical Device School: How to aud...

Post-Marketing Clinical Follow-up with Helene Quie (PMCF) from 2020-01-06T00:00

PMCF is a key element of the Post-Marketing Surveillance process. As there were a lot of questions about it then I decided to ask Helene Quie some questions while I was at Medica 2019. The post Po...

I wish you a Happy New Year 2020 with Monir El Azzouzi from 2019-12-30T00:00

This is the last episode of 2019 and I wanted to summaries the situation and introduce you to my 2020 projects. The post I wish you a Happy New Year 2020 with Monir El Azzouzi appeared first on Me...

6 ways to collect Clinical Data with David Rutledge from 2019-12-23T00:00

With the MDR, more and more clinical data are needed. But how will you collect them. David Rutledge will show you 6 ways to collect those data and the pros and cons for each of them. The post 6 wa...

Class I Medical Devices under MDR with Erik Vollebregt (PART 2) from 2019-12-16T00:00

Before to look at this episode, you should go to Part 1. On this second part we'll continue to discuss Class I up-classified situation and then pure Class I devices under MDR. The post Class I Med...

Corrigendum 2 – Changes for Class I Devices with Erik Vollebregt (Part 1) from 2019-12-09T00:00

The MDR Corrigendum 2 is changing the rules for some class I devices under MDD that are up classified under MDR. Let's see what manufacturers should do. The post Corrigendum 2 – Changes for ...

How to evaluate your Medical Devices in 3 Steps with Heikki Pitkänen? from 2019-12-02T00:00

If you have a product and you want to evaluate if this is a Medical Device, then you need to follow the 3 steps that we will discuss on this episode. Heikki Pitkänen's platform is providing a solu...

Responsibility of a Distributor in MDR & IVDR with Nicolaj Nitzsch from 2019-11-25T00:00

What is the role of a Distributor within the new MDR 2017/745 and IVDR 2017/746. This is the question that I asked my guest who is working as distributor of Medical Devices in Norway. The post Res...

Medical Device School: Product Development or Documentation creation? from 2019-11-21T00:00

When you are trying to create your product there is one question that you should answer: Should you focus on your product development or your documentation creation? Listen to our argument on this...

EUDAMED is delayed, so What? with Richard Houlihan from 2019-11-18T00:00

EUDAMED is delayed but what should do Medical Device manufacturers to continue be compliant. Richard Houlihan is a EUDAMED expert and will help us understand. The post EUDAMED is delayed, so What?...

Literature Search for your CER with Ed Drower from 2019-11-11T01:00

When creating your Clinical Evaluation Report or CER, you maybe need to perform a literature search. There is a certain method for that and we wanted to help you to understand it with Ed Drower fr...

Medical Device School: How to build a Gap Assessment Tool? from 2019-11-07T00:00:58

In this Bonus episode of Medical Device School we will talk about Gap Assessment tools. You know that when there is a regulation or something that you should put in place, you need to perform a ga...

How to validate an eQMS with Jacob Sjorslev from 2019-11-04T00:00:35

After episode 47 on how to implement an eQMS, Jacob Sjorslev is now telling us how to validate an eQMS. This is something mandatory now since ISO 13485:2016. So listen carefully and download the g...

How to implement an eQMS with Jacob Sjorslev from 2019-10-28T00:00:16

An eQMS can be a necessary tool for your Quality Management System. This is why it's implementation should be executed as a project. Jacob Sjorslev will be your instructor and tell what to do and ...

Medical Device School – Most important issues on your CAPA (ISO 13485) from 2019-10-24T00:00:29

On the Medical Device School segment, we will help you understand how to be better with your CAPA system. Stefan Bolleininger and Monir El Azzouzi are sharing with you their experience. The post M...

Medical Device Disruptions at Hospitals with Stefan Krojer from 2019-10-20T11:01:13

Some signs are raising from Hospitals regarding disruptions on Medical Devices. What is exactly the reason. Stefan Krojer will share with us his experience and a solution he is developing. The pos...

5 FDA Myths for Start-Ups with Justin Bushko from 2019-10-14T00:00:07

Justin Bushko from Concise Engineering will share with us 5 FDA Myths that exist on the Start-up world. Medical Devices Start-Ups should satisfy Investors and Regulatory, and this can create some ...

GDPR & MDR for Medical Applications with Jovan Stevovic from 2019-10-06T22:38:36

GDPR is also important for the MDR regulation. As we are developing Medical Device application, we should also implement GDPR on our development. Jovan Stevovic from Chino.io will help us understa...

Register your Medical Device in the US with Michelle Lott (FDA) from 2019-09-29T22:59:21

There are many ways to register a Medical Device in the USA and I propose you to listen to Michelle Lott that will tell you the basics of the FDA regulations. The post Register your Medical Device...

New rules for the In-Vitro Diagnostic Industry with Maurizio Suppo from 2019-09-21T23:01:15

In-Vitro Diagnostic Regulation will come later and we have time. Maurizio Suppo do have another opinion and as he is really passionate about this topic he will be providing some golden advice that...

Learn Post Market Surveillance with Natasha Bankowski from 2019-09-15T23:02:48

On this episode I invited Natasha Bankowski that is also called the PMS Queen to help us understand the Post Marketing Surveillance for Medical Devices. You can also meet her at TOPRA Symposium 20...

Product Equivalence for Clinical Evaluation Report (CER) with Helene Quie from 2019-09-07T23:10:02

This episode with Helene Quie from Qmed Consulting contains Diamond of Information. If you are lost regarding Product Equivalence for your CER, then you need to listen that and it will be clearer....

Episode 39 – Networking at Medical Device events with Lynda Wight from 2019-09-01T22:30:48

Networking at events can be a great experience or a disaster. On this episode we will help you to be prepared for it. We will use the TOPRA symposium as an example. The post Episode 39 – Net...

Episode 38 – Be the Best Candidate Ever with Mitch Robbins from 2019-08-26T00:00:19

How can you be considered the best candidate ever? This is what will be presented today by Mitch Robbins from the Anthony Michael Group. And learn also why he called his company with this name. Th...

Episode 37 – Usability & Human Factor with Sharon Ayd from 2019-08-19T00:00:26

Let's not talk about theory but really about experience when we are looking for Usability tests and Human Factors. Sharon Ayd will share with us a project where she was able to use these notions t...

Episode 36 – How to choose your PRRC with Erik Vollebregt from 2019-08-12T00:00:10

PRRC means Person Responsible for Regulatory Compliance. With the new Medical Device Regulation it is mandatory to have one at your company. Let's review everything about this role and help you to...

Episode 35 – Digitalization of QA RA with Michael Kania from 2019-08-05T00:00:56

Digitalization of QA RA is a concept that many Medical Company didn't adopt. But what can they win if they engage on it? This is the topic of today´s episode. The post Episode 35 – Digitaliz...

Episode 34 – Real-World Data for Medical Devices with Alethea Wieland from 2019-07-29T00:00:26

Real World Data is more and more important with all the new devices that can collect them. Then what can we do with them and how to present them to a regulator. The post Episode 34 – Real-Wo...

Episode 33 – Notified Bodies Lay Down Service with Erik Vollebregt from 2019-07-22T00:00:31

One important piece of the puzzle for the new Medical Device Regulation is about Notified Bodies. More and more we receive the information that some of them decide to Lay Down Service. What are th...

Episode 32 – Pakistan Registration Process with Muhammad Sohail from 2019-07-14T22:59:38

Pakistan Registration requirements for Medical Devices have been improved and leave more opportunities for Manufacturers. Muhammad Sohail, will share with us the situation of this market and the s...

Episode 31 – First Regulatory Affairs Job with Karandeep Badwal from 2019-07-06T23:05:15

Finding your first Regulatory Affairs Job can be a challenge. And Karandeep Badwal knows about that as he followed this journey. He is now Regulatory Affairs Contractor. Karandeep wanted to share ...

Episode 30 – Promotional Compliance with Darshan Kulkarni from 2019-06-30T22:59:57

The topic of Promotional Compliance is really important in the USA. As you will hear on this episode, advertisement is everywhere and most importantly, the advertisement for Healthcare Products. T...

Episode 29 – 5 Steps to create a QMS with Jason Lim from 2019-06-23T22:59:24

Jason Lim will reveal to us what are the 5 steps to create a good Quality Management System or QMS. The post Episode 29 – 5 Steps to create a QMS with Jason Lim appeared first on Medical Dev...

Episode 28 – OBL & OEM with Stefan Bolleininger – Part 2 from 2019-06-16T23:01:13

How an OEM or Original Equipment Manufacturer can help the OBL (Own Brand Labeller) to continue business? Stefan Bolleininger from Be-On-Quality will help us on this second part of the Podcast. Th...

Episode 27 – OEM & OBL Model with Stefan Bolleininger [Part 1] from 2019-06-10T01:30:35

The OEM and OBL model is under question with the new EU MDR and IVDR regulations. Stefan Bolleininger will help us understand how to continue to be compliant and continue business. The post Episod...

Episode 26 – IVDR preparation with Andreas Stange from 2019-06-03T03:30:39

Andreas Stange from TÜV SÜD will help us be prepared for the new IVDR or In-Vitro Diagnostic Regulation. This is a game changer for the manufacturers as more products are on the scope of a notifie...

Episode 25 – EUDAMED secrets with Richard Houlihan from 2019-05-27T03:00:19

EUDAMED is the new European Database for Medical Devices and this is something that can change completely the world of Medical Devices. For the consumers and the manufacturers. The post Episode 25...

Episode 24 – Myths about consultants with Thomas McMann from 2019-05-20T04:00:25

Are you hiring contractors or consultants for your projects? Do you know the difference or do you know what are the myths about them? Thomas McMann from EPM Scientific is sharing that with us. The...

Episode 23- TOP 10 criteria to select a CRO with Alethea Wieland from 2019-05-13T05:00:18

Alethea Wieland, President of Clinical Research Strategies will tell us what are the most important criteria to select a good CRO for your clinical trial project. The post Episode 23- TOP 10 crite...

Episode 22 – Clinical Trial with Alethea Wieland from 2019-05-06T05:00:56

What is a Clinical Trial or Clinical Investigation? And should a Medical Device Company start a Clinical Trial or perform a Clinical Evaluation? I invited Alethea Wieland from Clinical Research St...

Episode 21 – How to master Regulatory Affairs with Samantha Alsbury from 2019-04-29T05:00:20

For those that want to work on a Regulatory Affairs department, the path can be difficult. We are looking for people that are experimented but before to be experimented they should start somewhere...

Episode 20 – What is a Blockchain with Khuram Malik from 2019-04-22T05:30:39

Blockchain for Healthcare is a new Technology. On this episode, Khuram Malik will tell us what is Blockchain and how Medical Devices can use it. The post Episode 20 – What is a Blockchain wi...

Episode 19 – Rule 11 for Software Devices with Cyrille Michaud from 2019-04-15T03:30:43

Cyrille Michaud from MD101 Consulting is helping us to understand the new rule 11 to classify Software Devices in the European Union. This is a new rule so this creates a lot of discussion in the ...

Episode 18 – QA RA Recruitment situation with Petra Ognjenovic from 2019-04-08T02:00:53

Is it the right moment to move to another position if you are in Quality and Regulatory affairs? Petra Ognjenovic from SciPro Global is helping us to decode the situation on the recruitment market...

Episode 17 – Unannounced audit stories with Florent Guyon from 2019-04-01T04:00:47

On this new Episode, Florent Guyon from Nexialist is sharing with us his anecdotes regarding unannounced audit. He will also talk to us about a Master Degree he proposes at the ISIFC Biomedical En...

Episode 16 – From Disease to a Medical Device with Sean Hamilton from 2019-03-25T02:00:42

Sean Hamilton from War on Epilepsy is a Seanpreneur as he says on this episode. He is epileptic and this made him think that he can maybe create a Medical Device for people with the same condition...

Episode 15 – MDR & IVDR discussion with Erik Vollebregt Part 2 from 2019-03-18T03:00:17

On this second part of the podcast episode, Erik Vollebregt is continuing to tell us more stories on the background of the MDR and IVDR. We'll discuss about the differences between big and small c...

Episode 14 – MDR & IVDR stories with Erik Vollebregt (Part 1) from 2019-03-11T02:00:40

Erik Vollebregt from Axon Lawyer is explaining to us what is the EU MDR and IVDR. This will be a 2 part episode with a lot of anecdotes. Erik is also the author of the blog MedicalDevicesLegal.com...

Episode 13 – Brexit Talk with Richard Young from 2019-03-04T05:00:51

Richard Young from Sensus group talk to us about the Brexit Situation. His company is located in the UK and is helping Medical Device manufacturers to overcome this situation. Brexit date is plann...

Episode 12 – How to create an ISO Standard with Marcelo Antunes from 2019-02-25T05:00:22

Marcelo Antunes from SQR Consulting is walking us through the process of Standard creation. You'll understand how you can participate to it and why it is so important. We will also discuss about t...

Episode 11 – Medical Device Software Validation from 2019-02-17T09:40:20

Bill Stamm and Rafael Blanco from General Digital Software Services are helping us to understand Medical Device Software Validation. This process is becoming more and more important as the Healthc...

Episode 10 – Understand MDSAP with Angelina Hakim from 2019-02-11T06:00:18

On today’s show, I invited Angelina Hakim the CEO of Qunique which is an Agency helping customers on Regulatory projects and also provide some service as an auditor. She has […] The po...

Episode 9 – Entrepreneurial journey with Ivan Perez Chamorro from 2019-02-03T10:00:53

Show Notes This episode of the Medical Device made Easy Podcast is special as this is the first one I am doing with a guest. I have interviewed Ivan Perez […] The post Episode 9 – Entr...

Episode 8 – From Correction to Prevention with ODIAC from 2019-01-27T11:03:17

Learn one of the many methods to move your working area from Correction to Prevention with the ODIAC method. Don't try to find it on Google because I created it only for you. Learn how to solve is...

Episode 7 – Make your KPIs Green again from 2019-01-20T11:55:05

KPIs means Key Performance Indicators. This is an important part of the Quality Management System of a company. This is not specific to Medical Devices but you have to have […] The post Epis...

Episode 6 – What are the 6 types of Medical Device Audits from 2019-01-12T15:02:27

On this episode of the Medical Device made Easy Podcast I will tell you what are the 6 Types of Medical Device Audits. I know that when you are talking about audit on your companies, there are som...

Episode 5 – Medtech Prediction 2019 from 2019-01-06T11:42:13

2019 is here and as I read many media´s predictions for the medtech industry, I decided to also predicte myself what will be a trend. I will talk specifically about 2 axes which are Technologies a...

Episode 4 – UDI for Unique Device Identification from 2018-12-29T21:21:15

UDI for Unique Device Identification. You will need to understand what is happening with the UDI to be able to implement it. So let´s learn first about the vocabulary. The post Episode 4 – U...

Episode 3 – Is my Product a Medical Device in Europe? from 2018-12-20T14:04:48

Medical Device made Easy Podcast Episode 3- On this episode I help you to define if your product is a Medical Device in Europe? I know it sounds basic but you´ll see that the new Medical Device Re...

Episode 2 – New EU Medical Device Regulation MDR 2017/745 from 2018-12-16T17:43:53

The new EU Medical Device Regulation MDR 2017/745 will be in place by May 26th, 2020 but are you already aware of its content. Listen to this episode to know more. I provide you some information t...

Episode 1 – Introduction to the Medical Device made Easy Podcast from 2018-12-14T23:04:42

Within this first episode of the Medical Device made Easy Podcast I am introducing myself and also this podcast. Don´t forget to subscribe to it so you can be notified when a new episode is releas...