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Our trainings (also in-house training) are customised to the specific and individual needs of the customers. We provide international training on European regulatory aspects including:

  • CE marking of medical devices and IVDs
  • preparation of technical documentation
  • risk management according to ISO 14971
  • preparation of clinical evaluation
  • post-market surveillance activities
  • vigilance requirements
  • CAPA system handling
  • biocompatibility requirements
  • quality management systems according to EN ISO 13485
  • person responsible for regulatory compliance (PRRC) according to Art. 15, MDR, IVDR
  • medical device consultant according to §83 German Medizinprodukterecht-Durchführungsgesetz (MPDG)
Additional services

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MT Promedt Consulting offers a complete consultancy service for medical device manufacturers. Your business is our business. So whether you need first ideas or a second opinion: we’re here to listen – and ready to answer.

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