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 forDIN EN ISO 13485, DIN EN ISO 14971, DIN EN 1041, 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

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.

Final Work

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

Did you know?

There is a book from us:

Professionelles Risikomanagement von Medizinprodukten (Professional risk management)
Ein Leitfaden zur praktischen Umsetzung der DIN EN ISO 14971 (a guidance for pratical implementation of DIN EN ISO 14971)
von Dipl.-Ing. Dorte Kiecksee, Prof. Dr.-Ing. Erik Schwanbom
Herausgeber: DIN – Ausgabedatum 2015-09

(only available in German)