Regulatory Affairs Mastering IVD requirements on an international scale

The conditions under which IVDs may be placed on the respective target market are strictly regulated: From product development and production to market launch, companies must fulfill numerous requirements. What is additionally challenging is that regulatory requirements are constantly changing and becoming increasingly complex.

With our Regulatory Affairs team a partner is at your side who knows the requirements for international approval inside out. 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 IVD medical devices is complex – and therefore offers a high potential for optimization through a strategic approach.
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How may 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 and 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

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

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