Gap analysis for established product technical documentation

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.