strategic regulatory consulting
With detailed experience in a wide range of medical devices and in vitro diagnostic medical devices we provide complete support for European pre- and post-market compliance.
- support during CE conformity assessment procedures according to MDR (EU) 2017/745 and IVDR (EU) 2017/746
- preparation of technical documentation
- preparation of product risk management file according to. EN ISO 14971
- preparation of clinical evaluation for medical devices
- regulatory support on performance evaluation for in vitro diagnostics
- post-market surveillance (PMS)
- summary of safety and clinical performance (SSCP)
- review and gap analysis for technical documentation
- planning and reporting on biocompatibility activities according to EN ISO 10993-1 ff.
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.