Regulatory support for medical devices and in-vitro diagnostics
Our consulting services and seminars support you as a newcomer, start-up, manufacturer, distributor or supplier!
en.co.tec CONSULTING: Regulatory affairs and quality management for medical devices and in-vitro diagnostics. Professional support for ISO 13485, MDSAP, audits, risk management, gap assessment MDR-IVDR, technical documentation and much more.
With us you get individual support and customized advice!
en.co.tec ACADEMY: Practice-oriented training for medical devices and in-vitro diagnostics: in-house and public - on-site and ONLINE! From individual seminars to our online courses: REGULATORY SPECIALIST and MEDICAL SOFTWARE SPECIALIST to MBA Health Tech Management. We are also happy to outsource your training activities. For beginners and advanced learners!
As a technician from an early age, studying electrical engineering was foreseeable. My diploma thesis took me into the world of medical devices. It was already clear back then that mastering the regulatory requirements (in addition to excellent technology) was the key to success.
The fact that all the European directives and standards - some of which are now in their third edition - were in the process of being developed only becomes clear today in retrospect. This gave me the unique opportunity to experience this entire, dynamic process of establishing the European system of regulatory requirements for medical devices from the very beginning and in some cases (e.g. with regard to risk management) even to help shape it.
I am a member of standardization committees, lecturer at universities and universities of applied sciences, speaker at international congresses, author of internationally renowned publications, etc.