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Recorded Webinar

FDA Medical Device Regulation – Design Controls

timelapse 60 mins with 10-15 mins of Q and A

Note:

This webinar occured in the past
Along with recorded webinar, copy of presentation slides will be shared
Recorded Webinar can be played unlimited times

Speaker/Presenter

Short Abstract

Design controls have been a regulatory requirement since 1997, and medical device companies still struggle with implementing an effective design control process. “Design Control” is FDA’s term for how a medical device company manages the design, development, testing, and manufacturing of its products. ISO 13485 includes these practices in its “product realization” requirements. This webcast presents an overview of FDA’s design control requirements – regulatory requirements, a typical design control process, and tips for success.

The presentation will cover the following areas:

  • Design Control Requirements.
  • Why use Design Controls.
  • Tips for Effective Design Control.


Apply for this webinar

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