Metecon GmbH services

Services Medical Devices - Verification and Validation

Coordinating External Laboratories Services

Tests for electrical or biological safety or for other special topics are scheduled for your development project? We are there to coordinate the entire execution of tests in accredited test laboratories.

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.