Noncompliance among medical device developers typically falls under two areas: design control and document management. These two critical elements intersect in one place: the Design History File (DHF).
If your DHF is paper-based or hybrid (part electronic and part paper-based), the challenges grow exponentially. Discover insights that might help you address your DHF challenges. As well as the top 6 pains and recommendations for addressing them:
The Organization is Unprepared for Audits
The Design Review Process is Bumpy
It's Almost Impossible to Get the Signatures of Top Executives
It's Difficult to Implement Postmarket Change Control or CAPA
Finding Documents through a “Gatekeeper” is Inefficient
Managing DHF and Technical Dossier Can Require Two Teams