The market clearance procedures of the U.S. FDA and the EU (European Union) require the implementation of a suitable risk management process. Therefore, risk management is an integral part of product and process development, leading to more stable and safe products, but also increased efficiency by focusing on the essentials.
All established methods of risk management, in particular to ISO 14971, include three common steps:
- Identifying risks and hazards: risk identification
- Determining the cause and impact of risks: risk assessment
- Identifying measures to minimize risk: risk minimization
Our services include:
- Selection of the appropriate method of risk analysis
- Creating a Risk Management Plan
- Performing the risk analysis
- Documentation of results
- Monitoring of mitigation measures
The Capamed Advantage:
- You will receive a complete risk management file, compliant with ISO 14971.
- With these templates, your risk management documentation can be kept up-to-date throughout the post market phase.