Complying with FDA Design Control Requirements Using RM Principles

Medical device expert from MDM Engineering Consultants will walk through how implementing a good requirements management process helps facilitate compliance with FDA design control requirements by building a good foundation from which product development can be initiated.

Utilizing the “V” model as a guide, this webinar will show the correlation of good requirements management practices and each element of design control.

In this session, attendees will learn more about:

  • Understanding stakeholder needs and translating them into system requirements
  • Analyzing requirements for correctness and completeness
  • Defining requirements at the right level
  • Integrating the deliverables of the development process into a bidirectional trace matrix to show regulatory compliance.
  • Managing and controlling requirements changes