How To Improve Your Medical Device Design Reviews - a podcast by Greenlight Gurus Jon Speer + Medical Device Quality Regulatory Leaders, Entrepreneurs, Consultants, R&D Engineers

from 2019-11-07T15:07:38

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With nearly half a century of combine experience performing medical device Design Reviews between them; Michael Drues Ph.D., Jason McKibbin, and Jon Speer have the battle scars they want to help you to avoid.

They peel back the lens on what has worked for them over the years and how you can implement their proven strategies at your organization.

Design Reviews are clearly a topic that this group has some strong, and at times, counter intuitive thoughts on.

In this 24 minutes episode, our experts really get down to sharing actionable tips and advice that your team can start using today to help improve your Design Reviews.

They reveal their candid opinions and advice on a range of Design Review related topics including:

• Why Design Reviews are important?
• How do Design Reviews fit within Design Controls?
• Explain the concept of an “independent reviewer” and why this is necessary?
• When should Design Reviews take place? And how often?
• What should not be included within a Design Review?
• How are Design Reviews the same (or different) from a Phase Review?
• What actionable tips & advice do you have to improve Design Reviews?

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