risk-management-specialist

Medical device risk management under ISO 14971 involves planning, analysis, evaluation, control, and post-market surveillance. It provides structured workflows to identify hazards, assess probability and severity, implement controls, and apply ALARP principles throughout the product lifecycle.

Performing FMEA and FTA for medical device risk analysis requires evaluating potential failure modes and fault tree logic to identify hazards. These techniques feed into the ISO 14971 risk evaluation stage, helping determine acceptable risk levels using probability and severity assessments.

The ALARP principle in medical device risk control dictates that risks must be reduced to As Low As Reasonably Practicable. It serves as a decision framework within ISO 14971 to evaluate whether residual risks are acceptable after implementing risk control measures.

Yes, it provides templates and decision frameworks for creating a medical device risk management plan. These resources guide manufacturers through documenting the risk management process, defining acceptance criteria, and outlining post-market monitoring activities.

Setting up post-market surveillance for medical device risks involves monitoring residual risks and collecting production data after deployment. Under ISO 14971, this stage ensures continuous evaluation of risk control effectiveness and identifies newly emerging hazards during the product lifecycle.