Complying with ISO 14971 can be challenging. The ISO 14971 Medical Device Risk Management standard requires you to identify all hazards associated with your Medical Device, estimate and evaluate the associated risks, control the risks, and to monitor the effectiveness of all controls. Risk Management spans throughout the product life cycle from the design phase through the commercialization, production and post-production phases. Risk Management calls for careful planning and appropriate staffing to support the necessary activities.
We have expertise in the application of ISO 14971 risk management for medical devices and combination products, we can ensure you get the following deliverables completed:
- Risk Management Plan and Report
- Design Failure Mode Error Analysis (DFMEA)
- Process Failure Mode Error Analysis (PFMEA)
- Use Related Risk Analysis (URRA)
- Product Hazard Analysis (HA)
- Risk Analysis Matrix
- Clinical Risk Benefit Analysis (CRBA)
- Risk Management File
