en.co.tec GmbH

Founded

2000

Staff

5

Organization type

service provider

Region

Vienna

Cluster

LISAvienna
Human.technology Styria
Medical Technology Cluster

Offer

QM und regulatory consulting

In 2000 en.co.tec is founded by Dipl.- Ing. Martin Schmid. In the following years the company grows and the strategic partnership with the Center for Biomedical Technology of the Danube University Krems is established. en.co.tec builds up a network of cooperation partners. The focus is on consulting services related to development, regulatory affairs and QM for the medical device industry as well as on the academy, where practice-oriented training is conducted, also available as inhouse training.

Services:We offer consulting & training regarding regulatory affairs & quality management for medical devices and in vitro diagnostics. Professional support for ISO 13485, MDSAP, audits, risk management, gap assessment MDR/IVDR, technical documentation. Practice-oriented training for medical devices and in-vitro diagnostics: in-house and public - presence and ONLINE! From individual seminars to our online course: REGULATORY EXPERT to MBA Health Tech Management.