Will FDA or other regulatory bodies push back on a late entry into Design Controls? What are some of the critical tasks we should accomplish in feasibility testing to optimize our work under Design Controls?
The decision of when to enter Design Controls is often unclear and arbitrary and it's often wondered whether the additional overhead is even worth it.
If this is you, you're not alone. And you'll soon get answers to all your questions related to this topic.
This presentation explores key facets of late feasibility and early Design Controls during product development, including systems engineering best practices, regulatory involvement, and business risk.
You'll learn from leading experts Jamison Float, Sr. Biomedical Engineer at Priority Designs and Chad Gibson, Managing Partner at CMD MedTech who illustrate these key decision points through a case study approach to provide you with practical techniques to “flip the switch” between unregulated and regulated phases that occur throughout medical device development.
This presentation originally aired during the Greenlight Guru True Quality Virtual Summit, the first and only of its kind with over 30 of the top medical device experts from around the world who presented on top, trending topics segmented into three main focus tracks:
1) GO Track - Covering everything you need to know to get new devices to market with less risk
2) GROW Track - Covering proven best practices for advancing the success of your devices already on the market
3) COVID-19 Track - Covering practical insights into managing and leading medical device companies and teams during the pandemic
If you’d like to watch more related videos, browse through the full list of free replays from our GO Track of the True Quality Virtual Summit event: [ Ссылка ]
Plus, download the slides from this presentation for free here: [ Ссылка ]
Looking for a QMS solution to help you bring safer medical devices to market faster with less risk? Take a quick tour of Greenlight Guru's Medical Device QMS software: [ Ссылка ]
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