NEW MD REGULATIONS 2017/745 & 2017/746

European directives for the registration of medical device for CE marking are replaced by a european regulation applicable since May 2017. Manufacturers must register their products according to this new regulation.


Our audit center offers you:

  • An assessment with an analysis of the gaps in all or part of your system between past, current and future requirements, accompanied by a remediation plan.
  • An audit of your system in accordance with new regulations including an audit and observation report.

These two services can be extended to all your suppliers and/or service providers.







icone formationTRAINING

Our training offer includes :

  • European Medical Device Regulation – 2017/745 and 2017/46 (QR271).
  • MD and MD DIV technical documentation (QR272).
  • QMS – Medical Devices in Europe (QR280).

The above training courses can be customized to meet your specific needs, depending on the gaps identified after the assessment. These training courses can be conducted on site or remotely (virtual classes).




icone formationCOACHING

With our coaching service, we can accompany you in the:

  • Transition from 93/42 to Regulation 2017/745.
  • Transition from 98/79 to Regulation 2017/746.
  • Design of an improvement and upgrading plan for your QMS (Quality Management System).
  • Design of an implementation plan for Post-Market Clinical Surveillance.
  • Analysis of differences in registration practices outside Europe (USA, Canada, Brazil, Japan, Australia).




icone projet missionIMPLEMENTATION

Depending on your level of expertise and the availability of your teams, we work with you in:

  • Improving and upgrading your QMS (in line with ISO 13485 v2016 requirements, 21CFR820).
  • Upgrading your technical & regulatory files, DHF, DMR, CE Marking, 510k, RMP…
  • Quality assurance, quality system management, audit support (ON, customers…).