My Competence

Design & Development of medical devices for intensive care medicine, surgery and dermatology - in close cooperation with international suppliers.

CE certification for multiple medical devices classes 1 to 2b in Europe – in close cooperation with Notified Bodies.

Creation and updating of the technical documentation.

Preparation of clinical evaluations according to MEDDEV 2.7.1. Rev. 4

Establishment of Post-Market Surveillance Systems according to MEDDEV 2.12-1 Rev. 8

Implementation of the quality management system according to ISO 13485: 2016

GAP analysis Medical Device Directive (MDD) vs. Medical Device Regulation MDR)

Market launch of several medical devices for intensive care, surgery and dermatology in Germany and Europe.

Achievement of ambulatory reimbursement for several medical devices (reimbursement) in Europe.
Including:

  • Application according to § 137e German Social Code V (Germany), evaluation of treatment methods.
  • Application for Medical Aid Catalogues and Drug Codes.
  • Preparation of study designs for clinical trials and implementation to achieve the reimbursement of medical devices.


Integration of medical devices into DRG systems for hospitals.

Preparation of dossiers and documentation for FDA approval (510K, De-Novo), as well as for NICE (United Kingdom).

Several years of committee work at the German Medical Technology Association (BVMed) and at MedTech Europe.

Member of the Bioelectrochemical Society (BES).

Member of the German Association for Coaching & Training (dvct).

 

 

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