Episode Thumbnail
Episode 3  |  24:04 min

How To Improve Your Medical Device Design Reviews

Episode 3  |  24:04 min  |  11.07.2019

How To Improve Your Medical Device Design Reviews

00:00
00:00
This is a podcast episode titled, How To Improve Your Medical Device Design Reviews. The summary for this episode is: 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?
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?

More Episodes

Greenlight Guru Acquires CanvasGT: A Fire(less)side Chat

Greenlight Guru Acquires CanvasGT: A Fire(less)side Chat

Tips for Being Prepared Post-EUA (Emergency Use Authorization)

Tips for Being Prepared Post-EUA (Emergency Use Authorization)

Understanding the UDI System for Medical Devices

Understanding the UDI System for Medical Devices

Shaking Things Up: What's Next for the Global Medical Device Podcast

Shaking Things Up: What's Next for the Global Medical Device Podcast

How Augmented Reality (AR) is Revolutionizing Healthcare

How Augmented Reality (AR) is Revolutionizing Healthcare

Why FDA is Prioritizing Clinical Decision Support Software & Why You Should Care

Why FDA is Prioritizing Clinical Decision Support Software & Why You Should Care