Design Control is a requirement from the FDA as laid out in 21 CFR.820. It is the basis for how medical device companies in the United States (or those planning on market in the United States) set up a quality system surrounding the designing and development of their medical devices. We will review what design control is, using examples to better have an understanding, and then see how Nelson Labs can support sponsors with design control requirements.
Things that will be learned by attending this webinar:
- The Design Control Process and Flow
- The place of CRO’s within the Design Control Process
- How Nelson Labs can support sponsors throughout Design Control