Challenge: A Class IIb medical device manufacturer received major nonconformities related to risk management during their MDR surveillance audit, threatening their certification status.

Solution: MDx conducted a comprehensive risk management file review, facilitated new risk analysis sessions, and implemented a revised ISO 14971:2019-compliant risk management process.

Result: All nonconformities closed within the required timeframe, with MDx’s approach receiving positive feedback from the Notified Body for its thoroughness and compliance.