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Question 1 of 30
A medical device company, \"MediCorp Solutions,\" is undergoing an ISO 13485:2016 audit. During the audit, the lead auditor, Ms. Anya Sharma, is reviewing MediCorp\'s risk management processes. She notes that MediCorp has meticulously documented risk assessments during the design and development phase of their new infusion pump, \"InfusaSafe,\" and has implemented robust risk control measures. However, Ms. Sharma finds that MediCorp\'s post-market surveillance plan for InfusaSafe is limited to passively collecting customer complaints through their website and has no active mechanism for systematically gathering data on device performance in real-world clinical settings. Considering the requirements of ISO 13485:2016 and the importance of continuous risk management, what is the MOST significant concern Ms. Sharma should raise regarding MediCorp\'s approach to risk management for InfusaSafe?
The lack of active post-market surveillance mechanisms may prevent MediCorp from identifying and addressing potential safety issues that emerge after the device is released, hindering continuous risk management as required by ISO 13485:2016.
MediCorp's adherence to risk assessment during design and development sufficiently addresses the requirements of ISO 13485:2016, making extensive post-market surveillance redundant.
Focusing solely on customer complaints is the most cost-effective method for post-market surveillance, aligning with the resource management principles of ISO 13485:2016.
As long as MediCorp complies with FDA regulations for reporting adverse events, their post-market surveillance plan is adequate, regardless of the ISO 13485:2016 requirements.

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