strategic regulatory consulting
With detailed experience in a wide range of medical devices and IVD’s we provide complete support for European and international pre- and post-market compliance.
- strategic regulatory compliance consulting
- technical and regulatory due diligence
- reimbursement strategies
- product and production risk management
- CE marking
- preparation of technical documentation and design dossiers
- clinical evaluation
- post-market surveillance
- medical device vigilance reporting
- international product registrations
- interims management
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.