3.5. Continuous Monitoring
Process of data collection, trending, monitoring, and analysis used for design verification and monitoring of medical devices.
Management Reviews
Internal Audits
Product Risk Review
Standard and Regulation Change Impacts
Periodic assessment of the QMS’s performance and effectiveness.
Regular evaluations of the company's processes and procedures to ensure compliance with established policies and regulations.
Ongoing assessment and mitigation of potential risks associated with the medical device throughout its lifecycle.
Identifying and addressing the implications of any changes in applicable standards or regulations.