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Question 1 of 30
MedTech Solutions, a manufacturer of Class II medical devices, is undergoing an internal audit of their Quality Management System (QMS) based on ISO 13485:2016. During the audit, a significant gap is identified: while the design and development phase incorporates thorough risk analysis and mitigation for potential device failures, the post-market surveillance system primarily focuses on tracking customer complaints and adverse event reports. There is limited evidence of proactively analyzing this post-market data to reassess the effectiveness of existing risk control measures implemented during the design phase or to identify previously unforeseen hazards associated with long-term device use. Considering the requirements of ISO 13485:2016 regarding risk management throughout the entire product lifecycle, what is the MOST critical corrective action MedTech Solutions needs to implement to address this gap and ensure compliance with the standard?
Integrate a systematic process for analyzing post-market surveillance data to identify trends, reassess risk control effectiveness, and update the risk management file accordingly, including procedures for triggering design changes or corrective actions based on post-market findings.
Increase the frequency of customer satisfaction surveys to gather more comprehensive feedback on device performance and user experience, without necessarily linking this feedback directly to the risk management process.
Conduct a one-time comprehensive review of all existing risk assessments to ensure they align with current regulatory requirements, independent of ongoing post-market surveillance data analysis.
Implement a new training program for the sales and marketing teams to improve their ability to identify and report potential device-related issues based on customer interactions, without establishing a formal link to the risk management process.

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