trainings
Our trainings (also in-house training) are customised to the specific and individual needs of the customers. We provide international training on European and US FDA regulatory aspects including:
- CE marking of medical devices
- preparation of technical files
- risk management according to ISO 14971
- preparation of clinical evaluation
- post-market surveillance strategies
- vigilance requirements
- CAPA system handling
- vigilance master plan
- biocompatibility evaluation
- toxicological evaluation of extractables/leachables
- quality management systems
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.