Metecon GmbH services

Technical Documentation

Develop and Maintain Services

Primarily, the technical documentation serves as proof of compliance with regulatory requirements for market access; in Europe, that is compliance with the MDR general safety and performance requirements.

Risk Management Services

Both the medical device regulation and different harmonized standards require a risk management process. EN ISO 14971 describes a process for the application of risk management to medical devices. The standard offers a procedure enabling the manufacturer to identify, assess, and control the risks linked to its medical device.