Mock EU Notified Body Audit

Startup medical device companies in business of design develop and market innovative catheter-based technologies for the treatment of certain structural heart defects.

Medical Device Company was in the process of obtaining CE mark for a class III medical device. Added a new manufacturing facility (with clean rooms etc.) and expecting a surveillance audit from a notified body. The client needed internal audit support for checks and balance to prepare the team for the upcoming EU notified body audit.

BridgeMed solutions consultant guided the company to checks and balances and identified the potential audit findings from the notified body and helped the company address them.