In order to remain competitive in the competitive and strong regulated healthcare market and to launch future-oriented, standards-compliant and billable products, sound knowledge of legal regulations and common standards is of great importance. With our support in Regulatory Affairs, we provide you with up-to-date knowledge of laws, standards and standards, to provide you the opportunity to focus on your core competencies.

senetics Consulting helps you to introduce the standards and regulations in your company and to stay up to date.

We support you with:

Regulatory Affairs:

  • Approval EU according to the “old” regulations
    • MDD (93/42/EWG)
    • IVDD (98/79/EG)
    • AIMDD (90/385/EWG)
  • Approval EU according to the „new” regulations
    • MDR (2017/745),
    • IVDR (2017/746)
  • Approval USA according to
    • FDA 510(k) Premarket Notification
    • FDA Premarket Approval (PMA)
  • Implementation of the new MDR and IVDR in operation
  • Health economic view

Technical documentation according to current requirements:

  • Creation and maintenance of the technical documentation according to MDR, IVDR
  • Revision of your technical documentation after audit deviations
  • Clinical evaluations according to MEDDEV 2.7 / 1 REV. 4 (MDD / MDR)
  • Clinical tests according to DIN EN ISO 14155
  • Position of the “Security Officer” according to §5 sentence 1 & 2 MPG
  • Position of the “Responsible Person for Regulatory Requirements” according to EU Regulation 2017/745 (MDR) (Article 15)

 

Regulatory Affairs