risk-management-specialist

Implement ISO 14971 risk management by initiating the planning workflow to define device scope and acceptability criteria, followed by hazard analysis, risk evaluation, control selection, and post-production monitoring.

The best way to conduct FMEA and hazard analysis is using standardized workflows that identify device hazards, evaluate risks, and select controls to ensure regulatory compliance and patient safety.

Yes, you need to define acceptability criteria during the initial risk management planning phase to establish the scope and thresholds for evaluating medical device risks.

Yes, you can use this framework for post-production risk monitoring as it covers end-to-end lifecycle activities including post-production evaluation for medical devices.

Yes, this workflow supports benefit-risk analysis by providing structured evaluation and control selection processes to ensure medical devices meet stringent regulatory approval requirements.

ISO 14971 compliance is necessary for Class II medical device development to establish a robust risk management process that ensures patient safety and meets regulatory requirements throughout the lifecycle.