How to Design for Compliance with IEC 60601 - a podcast by Greenlight Gurus Jon Speer + Medical Device Quality Regulatory Leaders, Entrepreneurs, Consultants, R&D Engineers
from 2019-11-07T15:07:12
Have you ever designed a medical device that has electrical components? Was it frustrating to go through the electrical safety testing - the IEC 60601 standards?
Claus Roemer Andersen, a compliance expert from Roemer Consulting, shares his experiences and advises us on how to design for compliance with IEC 60601.
After all, a lack of electrical compatibility can be detrimental to medical devices and the patients who use them.
IEC 60601 documentation is a lot to digest, which is a major challenge. But that does not mean you should neglect those standards. Applying the standards and making changes early on adds value and saves your company a lot of money.
Some of the Highlights of the show include:
-Road to Compliance: Design specific technical requirements during the early phases of product development, and perform design reviews and pre-testing.
-How to integrate design input requirements from a risk-management perspective.
-Why IEC 60601 standards are difficult for most people to navigate.
IEC 60601 has 8 specific things you have to address in your risk-management process, but they don’t fit into or make sense in a typical risk analysis table.
-The reason why the FMEA tool is not a useful tool regarding electrical safety: It is a single-fault failure, which is not sufficient.
-Understand who will be using a product and in what kind of environments because that shapes what you need to do regarding electrical safety.
-If you don’t follow standards, you face expensive and time-consuming redesign or you have to defend the effectiveness of your risk analysis.
-The days of “I Promise” statements for electrical safety are gone, and they make for delays and redesign challenges.
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