FDA Design Control regulations defined in 21 CFR 820.30 have been in place for 20 years now, yet year after year they continue to be one of the top issues cited during inspections.
This does not, and should not, be the case for your medical device company.
Join us for this free, two-part webinar series presented by two of the world's leading experts on the topic to learn how to implement a design control process that will not only ensure compliance but will actually benefit your product development efforts.
The importance of getting your intended use right up front
The difference between a user need and a design input that's verifiable
What stakeholders need to be involved in the process and why
When and how many design reviews you should hold
Why FMEA alone is NOT risk management and how to integrate risk into the design and development process
Why your design outputs need to be more than a drawing and their relationship to your DMR
How usability and human factors fits into the overall product development
Making sure you build the correct device and build it correctly with design V&V
Common mistakes people make during design transfer to production and how to avoid them
When you can and should make your regulatory submission
Founder & CEO
Medgineering & QuickConsult
Founder & VP QA/RA