Did you know why we can do what we can?

Memberships  |  Standardization  |  Further education

To insure having always the current knowledge, we are working active as experts with:

DIN NA 063-01-13 AA – mirror committee for DIN EN ISO 13485, DIN EN ISO 14971, DIN EN ISO 20417, DIN EN ISO 15223 and more.

ISO TC 210 Quality management and corresponding general aspects for medical devices
ISO TC 210 WG 6 Post Market Surveillance

LifeScience Nord e.V. – active member in working group regulatory affairs

FFM e.V. Forum for medical devices

RAPS Chapter Germany (Regulatory Affairs Professionals Society)

To insure having always the current knowledge, we further our education also by solving of current issues in the form of bachelor or master theses,
Participation on external trainings and in-house trainings.

University theses

If you need more information, ask for our personal Curriculum Vitae.

Did you know?

We wrote a book:

Professionelles Risikomanagement von Medizinprodukten
Ein Leitfaden zur praktischen Umsetzung der DIN EN ISO 14971 im Fokus der MDR und IVDR-Anforderungen
2. aktualisierte und erweiterte Auflage
Von Dorte Kiecksee – Rainer Klatt – Erik Schwanbom
Ausgabedatum 2023-04

(only available in German)