Metecon GmbH

Metecon provides the full range of regulatory compliance services for your medical device/IVD: Since 1999, we have been a strategic partner to our customers in the creation and maintenance of technical documentation, in the verification and validation of their products, in clinical affairs and regulatory affairs and in the optimization of quality management processes. The regulatory requirements are diverse and complex - we quickly find the best solution for you.

• Strategic consulting,
• Review, revision & creation of documents within the scope of EU & international approval,
• Review, revision & creation of an adequate QM system,
• Knowledge transfer to your team with customized solutions; in the project or with the Metecon Academy,
• assumption of complete manufacturer responsibility,
• support in the search for and communication with test laboratories, CROs and/or notified bodies,
• we assume responsibility as EU-REP, CH-REP and/or PRRC.

• 'We supply all regulatory services. This releases immense synergy effects for your product.
• We put together project teams according to your needs. Thanks to the size of our company, we can draw on the full range of resources.
• Whatever expertise you need, we are ideally positioned:
• Experience with various classes of medical devices and IVDs,
• Expertise in projects of varying duration and complexity,
• Experience with customers of all sizes.