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 in connection with development, accreditation and quality management for the medical device industry.
Subsequently, en.co.tec starts its involvement in international standardization committees, Austrian institutions and clusters, the Austrian Standards Institute and the German DIN, in order to push knowledge and experience exchange on a broad level and to make it useful for its customers.
As early as 2003, en.co.tec started as an expert in development, accreditation and quality management for medical devices with lecture series at renowned institutions in order to pass on the knowledge gained from standardization committees.
In 2008, these activities are bundled in the en.co.tec Academy. They include open seminars as well as in-house trainings for medical device manufacturers, often combined with consulting services. Step by step, the offer is expanded and today also includes training for in-vitro diagnostics manufacturers and medical software and app manufacturers.
Exchange, cooperation and networking
Networking and exchange within the industry has been a major concern for us from the very beginning. We support both newcomers and experienced manufacturers of medical devices and in-vitro diagnostics with joint activities such as seminars or expert consultation days with industry associations such as the Austrian Federal Chamber of Commerce, Human.technology Styria, Standortagentur Tirol, LISAvienna, Medizintechnik-Cluster Oberösterreich and Forum MedTech Pharma.
The EU regulations as a challenge
Since 2017, our focus has clearly been on supporting the implementation of the new requirements of the EU Medical Device Regulations (MDR) and In-vitro Diagnostics Regulations (IVDR). For all pioneers, there were already the “Open Lectures” in 2017, where the requirements were worked out in small groups in a practice-oriented manner. After that, the seminar offers, training courses as well as consulting services for gap analysis and implementation of MDR and IVDR started.
In recent years – due to the new EU regulations – the need for consulting services in the areas of medical device software & apps and in-vitro diagnostics in particular has been rising sharply.
Regulatory Conference for Medical Devices and IVD
Our first Regulatory Conference, which we have since organized together with LISAvienna, took place on November 7, 2017 at the FH Campus Wien. Since then, this event has become an elementary major event and annual fixture among industry events.
The goal has remained the same over the last 20 years!
We support our customers with consulting and training services to bring innovative medical devices and in-vitro diagnostics to market quickly and successfully!
Our services at a glance:
- Introduction of quality management systems according to ISO 13485 and ISO 9001,
- support in the development and accreditation of medical devices and
- lectures and seminars on current topics – such as the new EU regulations for medical devices & IVDs