ISO 14971 describes the risk management process for medical device manufacturers and their accessories. Risk management is an important component in the development, production and even after the placing on the market of medical devices.
The expertise of sentics in all life cycle phases of a medical device guarantees you an optimal coverage of these essential requirements of your products.
senetics supports you with:
- The implementation of the risk management process according to ISO 14971
- Identification of hazards
- Risk evaluation
- Measurement specification
- Risk-profit analysis