trainings
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)
Contact us
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.