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Question 1 of 30
Dr. Anya Sharma, the Quality Director at MedTech Innovations, is tasked with transitioning the company\'s Quality Management System (QMS) to align with ISO 13485:2016. MedTech Innovations manufactures a range of Class II medical devices, including infusion pumps and patient monitoring systems. During a recent internal audit, a significant gap was identified in the company\'s post-market surveillance process. Currently, the process primarily relies on reactive measures, such as addressing customer complaints and investigating reported adverse events. There is limited proactive data collection or analysis to identify potential risks before they manifest as incidents.\n\nTo address this gap and ensure compliance with ISO 13485:2016, which of the following strategies should Dr. Sharma prioritize to enhance MedTech Innovations\' post-market surveillance system? The strategy should demonstrate a deep understanding of the standard and its application in a real-world medical device manufacturing context.
Implement a comprehensive system for proactively collecting and analyzing post-market data from diverse sources, including customer feedback, field reports, regulatory notifications, and scientific literature, integrating this data with the organization's risk management processes to identify trends, patterns, and emerging risks, and validating the effectiveness of the system to ensure it meets its intended objectives and aligns with the overall quality management system.
Focus primarily on improving the efficiency of the customer complaint handling process and ensuring that all reported adverse events are thoroughly investigated and documented, as this is the most direct way to address immediate safety concerns and demonstrate compliance with regulatory reporting requirements.
Establish a formal process for conducting annual surveys of healthcare professionals to gather feedback on device performance and identify areas for improvement, while relying on existing internal data sources for risk assessment and management.
Develop a detailed procedure for tracking and trending warranty claims and service requests, using this data to identify potential manufacturing defects and implement corrective actions, without necessarily integrating this information with broader risk management activities or post-market data sources.

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