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:

1. The Organization is Unprepared for Audits
2. The Design Review Process is Bumpy
3. It’s Almost Impossible to Get the Signatures of Top Executives
4. It’s Difficult to Implement Postmarket Change Control or CAPA
5. Finding Documents through a “Gatekeeper” is Inefficient
6. Managing DHF and Technical Dossier Can Require Two Teams

Please fill the below form to download

Download