Welcome
Consulting for Quality Management and Medical Devices
As engineer for biomedical technology with long lasting professional experience I offer personal and custom-made support for the conformity assessment of your medical devices or the set-up of a quality management system.
My main focus of business is
- establishing of quality management systems according to the standards
- EN ISO 13485
- EN ISO/IEC 17025
- EN ISO 9001
- compiling technical files - especially in the field of non-active medical devices
- assisting companies as external quality representative and auditor