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The Complete Guide to FDA Design Controls

Free, On-Demand Two-Part Webinar Series (90 Minutes Each)

Access the Free On-Demand Webinar Series

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.


In Part 1, you'll learn about Intended Use, User Needs, Design Inputs, Design Reviews, Design History File (DHF) and Risk Management.
Specifically:
  • 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


In Part 2, you'll learn about Design Outputs, Device Master Record (DMR), Design Verification and Validation (V&V), Design Transfer and Regulatory Submissions.
Specifically:
  • 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 


 

Presenters

david_amor_round

DAVID AMOR
Founder & CEO
Medgineering & QuickConsult

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JON SPEER
Founder & VP QA/RA
greenlight.guru

greenight.guru

About greenlight.guru

greenlight.guru's beautifully simple Quality Management Software helps medical device companies bring devices to market faster while reducing risk and ensuring compliance.  


 

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About Medgineering

Gone are the days of hiring high-priced consultants to develop, execute and guide quality and compliance work. Medgineering offers flexible, customizable solutions to your consulting needs – and at a fraction of the cost of traditional consulting firms.


 

 

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