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 at Danube University Krems is established. en.co.tec builds up a network of cooperation partners. network of cooperation partners The focus is on consulting services in connection with development, approval and quality management for the medical device industry.
As a result, 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 promote the exchange of knowledge and experience on a broad level and make it useful for its customers.
Academy
As early as 2003, en.co.tec, as an expert in the development, approval and quality management of medical devices, began giving lecture series at renowned institutions in order to pass on the knowledge gained from standardization committees.
These activities will be continued in 2008 at the en.co.tec Academy in 2008. They include open seminars and in-house training courses for medical device manufacturers, which are often combined with consulting services. The range is gradually being expanded and now also includes training courses for in-vitro diagnostics manufacturers and medical software and app manufacturers.
Cooperation with universities of applied sciences
In 2010, our Managing Director Martin Schmid starts lecturing at the University of Applied Sciences Upper Austria for the first time. Several teaching assignments followed.
The first talks with the UAS Technikum Wien took place in December 2019. Is there a lack of a special degree course on regulatory (MDR-IVDR) for medical devices in Austria? Immediately after the LISAvienna Regulatory Conference 2019, we will start planning what content would be important and how this could be implemented in a Master’s course.
In fall 2022, the first students will finally be able to start the new MBA Health Tech Management at the Technikum Wien Academy. And the first graduates will complete their studies in summer 2024!
We are a proud cooperation partner for this MBA – all regulatory courses are taught by en.co.tec.
Exchange, cooperation and networking
Networking and exchange within the industry has been very important to 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 Economic Chamber, Human.technology Styria, Standortagentur Tirol, LISAvienna, Medizintechnik-Cluster Oberösterreich, ecoplus NÖ, Innovation Salzburg and Bayern Innovativ.
Focus on medical software & apps
Software now plays a central role in the world of medical devices. Whether embedded software, medical apps or artificial intelligence (AI), questions about EN 62304, EN 82304 or AMII TIR45 arise immediately.
With more than 15 years of experience in implementation with leading European manufacturers, we support you with tried-and-tested solutions.
With the help of en.co.tec, mySugr succeeded in launching one of the first medical apps – the “mySugr Logbook” – as a medical product in cooperation with the notified body TÜV SÜD Product Service GmbH. We succeeded in doing real pioneering work in this domain, from which you can benefit today.
The EU regulations as a challenge
Since 2017, our focus has clearly been on supporting the implementation of the new requirements of the EU regulations for medical devices (MDR) and in-vitro diagnostics (IVDR). The “Open Lectures” were held in 2017 for all pioneers, where the requirements were developed in small groups in a practice-oriented manner. This was followed by the launch of seminars, training courses and consulting services for gap analysis and implementation of the MDR and IVDR.
In recent years, the need for advice in the areas of medical device software & apps and in-vitro diagnostics in particular has risen sharply due to the new EU regulations.
Regulatory conference for medical devices and IVDs
Our first Regulatory Conference, which we have been organizing together with LISAvienna ever since, took place on November 7, 2017 at the FH Campus Wien. Since then, this event has become an elementary major event and an annual fixture among industry events.
The goal has remained the same over the last 25 years!
We support our customers with consulting and training services to bring innovative medical devices and in-vitro diagnostics to market quickly and successfully!
