Regulatory Affairs: managing international requirements

Worldwide there are strict regulations as to the prerequisites a medical device has to fulfill to be launched on the respective market; from product development to market launch, companies must meet numerous requirements. An additional challenge: regulatory requirements keep on changing constantly and become more and more complex.

With our Regulatory Affairs team, a partner is at your side who knows the requirements for international approval in detail. Together we develop the ideal approval strategy for your product and your target market and provide relevant support so that your product is quickly approved for the market.

International approval of medical devices is complex – and therefore a strategic approach holds much potential for optimization.
Schedule a free initial consultation now.

Ensure Your Success: Transitioning Your Technical Documentation under the MDR

The new EU regulation (2017/745) has been in effect since 2017, and the transition periods will soon expire. It is urgently necessary to act quickly now to meet the requirements of the MDR. Our whitepaper series provides you with valuable tips and guidance for transitioning your products. Use them as a guide to ensure that your medical devices meet the new standards. Take the necessary actions now and stay successful in the market!

(Available only in German Language)

Click here for the free whitepaper download.

How can we support you?

Different countries, different customs – that is all the more true in the context of certification and market entry. Use our know-how, stay on the safe side.

International approval

“A goal without a plan is just a wish” -
Let us develop the ideal strategy for you together at an early stage to ensure your international success.

Approval strategy

As your European Authorized Representative (EC-REP/EU-REP) or Swiss Authorized Representative (CH-REP), we ensure the regulatory requirements of your target market and provide comprehensive support for your regulatory compliance.

Representative Services

Fit for the future with the Metecon Academy

Each of our workshops and in-house courses provides sustainable knowledge and know-how in the areas of technical documentation, regulatory affairs and QM and is always exactly tailored to your needs.

Our customers use our workshops with our experts:
to keep themselves and their team up to date with the latest knowledge and/or to go into intensive exchange with us and gain clarity in the face of a current challenge about a specific description of objectives and the project strategy.

Through the operation of our own trainee academy, our comprehensive training material is always up to date.

Let us find out together what your team needs!

Workshop topics:

  • Implementation of IVDR for technical documentation and QM
  • Risk management
  • Usability
  • Biological safety
  • Clinical affairs
  • Software
  • Approval
  • Quality management

Contact us