Certbie
Question 1 of 30
MedTech Solutions Inc., a manufacturer of Class III implantable medical devices, is undergoing an ISO 13485:2016 transition audit. The auditor, Ms. Anya Sharma, observes that while the company has implemented a risk management process for product design and development, there is limited evidence of risk assessment related to the effectiveness of their post-market surveillance activities and the potential impact of process changes on product safety. Furthermore, the documented procedures for risk management do not explicitly address how ISO 14971 principles are integrated into the overall Quality Management System (QMS). During the audit, a recent field complaint regarding a device malfunction was traced back to a minor change in the sterilization process, which was not adequately assessed for potential risks. Considering the requirements of ISO 13485:2016 and its relationship with ISO 14971, what is the MOST critical area for MedTech Solutions Inc. to address to ensure compliance and improve the effectiveness of their QMS?
Enhancing the integration of ISO 14971 principles into the QMS by expanding risk assessment activities to include post-market surveillance, process changes, and other relevant areas, ensuring documented procedures reflect this comprehensive approach and that records of risk management activities are maintained throughout the product lifecycle.
Focusing solely on the technical aspects of product design and development, ensuring that all design inputs and outputs are thoroughly documented and verified, and conducting regular design reviews to identify and mitigate potential design-related risks.
Prioritizing the implementation of a robust corrective and preventive action (CAPA) system to address any identified nonconformities, ensuring that root cause analysis is conducted effectively and that corrective actions are implemented and verified in a timely manner.
Allocating additional resources to training and development programs for employees involved in the manufacturing process, focusing on improving their technical skills and knowledge to reduce the likelihood of manufacturing defects and product malfunctions.

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