Showcase Swiss Medtech Expo 2019

Gap analysis for established product technical documentation

To continue offering his products on the market, a customer had to check the documentation of existing product lines and adapt it to current regulations. With the support of EXCO, he was able to close the gaps in the shortest possible time and pass the subsequent TÜV audit.

  • EXCO examines your processes and documentation for compliance with the legal requirements.
    EXCO examines your processes and documentation for compliance with the legal requirements.

Gap analysis for established product technical documentation

EXCO reviewed the complete documentation of the product lines currently on the market and highlighted the discrepancies as compared to the current regulatory standards

EXCO created a dossier with lists of performance characteristics for the diagnostic medical device. To prove the performance, EXCO researched study documents in the relevant product technical documentation and client archives. EXCO also compared the study reports and resulted with the current regulatory requirements (e.g.) DIN EN ISO 18113, CLSI) and the current client standard. EXCO then assessed whether the completed studies satisfy the current regulatory standards, identified the discrepancies, and ensured the closing of the gaps.

 

Client benefits

  • The client gained an overview of the gaps in the product technical documentation.
  • A plan could be implemented in order to close these gaps so that the product satisfied the current requirements as specified by the authorities once again.
  • The subsequent TÜV audit was passed.

 

 

Related topics (2)

Regulation

94 items

Consulting

75 items