Our Team

Due to my many years of experience as a quality manager at an international medical device manufacturer and my work as a trainer and auditor, I know the normative and legal requirements as well as practical ways of implementing external requirements correctly and efficiently. My main competences are sterilization processes and clean rooms, the implementation of quality requirements in production, validation and the development of management systems according to ISO 13485.

Open source software and hardware related programming have always been my favorite topics. To develop a medical device in one of these areas requires experience and expertise beyond mere technology. For the realization of projects I support you with my special knowledge, from the idea to the finished product up to the market surveillance.

I interpret my role as a consultant as a long-term cooperation with companies in the implementation of ideas in the fascinating field of medical technology. With my broad expertise and my professional network I am at your disposal to jointly master the diverse challenges of this field.

My professional passions include the clinical investigation of medical devices and the performance evaluation of IVDs.

The medical technology sector is constantly expanding and it is becoming more and more difficult to keep track of the documentation and guidelines required for the individual products in order to obtain the necessary certifications.

I see it as my mission to support the companies on this complex path.

The constantly growing degree of innovation in medical technology involves not only positive aspects such as easier work for doctors and improved quality of life for patients, but unfortunately also high risks. Therefore, I see it as my duty to support companies in the medical technology sector in the development of their products.

My main professional focus is on the one hand usability engineering in order to optimally implement the user-product interface and on the other hand IT risk management in order to analyze and manage the risks of connecting medical devices to the medical IT network of a hospital. As RnB project manager it is my duty to lead the entire project team and to always keep it up to date on the basis of clearly arranged and visually designed weekly reports.

In science, insignificant seeming decisions in project planning can lead to enormous problems in the project's later stages. Careful planning of the study design, including all the subsequent steps, including statistical evaluation, is essential for the success of the project. As a consultant and active scientist, it is my goal to support and accompany clients in the best possible way in the planning and evaluation of studies.

As a lawyer, lecturer and author on legal topics, I have the necessary legal competence to provide advice on questions of medical law (liability, medical product law, etc.) due to my work as a lawyer, lecturer and author. I am also happy to handle the preparation of the necessary contracts, for example in the context of clinical trials.

Martin Schmid has been Managing Director and Senior Consultant of en.co.tec Schmid KG, Engineering & Management Consultancy for Development, Approval and Quality Management for Medical Devices in Vienna since 2000.

He has extensive regulatory and technology experience in the field of active and inactive medical devices and in-vitro diagnostics in the field of regulatory compliance and quality management for medical device manufacturers.

For many years he has been lecturer / trainer at numerous en.co.tec seminars and en.co.tec in-house trainings, at the universities of applied sciences Upper Austria and Wiener Neustadt, at the Danube University Krems and all Austrian medical technology clusters.

He is a member of the CMI (Regulatory Compliance Initiative of the Federal Ministry of Health / Department of Medical Devices) as well as of international standardization committees.

As a consultant, I support my clients taking into account holistic and sustainable aspects. Not only the technical side, but also the efficient team structure and team development are central components of the order processing. Each client has a specific problem, therefore the developed solutions are individual. The projects are implemented in the shortest possible time, using resources efficiently and achieving the agreed quality goals.

With many years of experience in various areas of the pharmaceutical industry, including quality assurance, quality control and internal as well as external audits of individual areas, I am able to comprehensively identify requirements and integrate solutions tailored to customer needs. The integration of the systems and the necessary knowledge in the companies is carried out under special consideration of the regulatory requirements.

Within the scope of my consulting activities for companies, I try to establish not only the implementation of the required systems, but also the knowledge within the company.

Since September 2013 I have been managing partner of HYGline GesmbH hygiene issues & management. I can apply my decades of experience as a practitioner and develop new projects. I am particularly proud of the unique development of the HYGline database. It enables the customer to access his hygiene-relevant data quickly and clearly. For him, this means a decisive “more” security for his hygiene management as well as the continuous improvement of hygiene standards in medical facilities. The EICHY material compatibility database was created on the initiative of HYGline. EICHY (European Interdisciplinary Committee for Hygiene & Compatibility Testing of Medical Devices) offers an electronic platform that provides interested parties with free information on the correct hygienic preparation of medical devices. The platform is aimed primarily at medical professionals and manufacturers of medical devices.

Through my many years of work in the chemical industry, my teaching activities at Upper Austrian technical colleges and as an auditor, I am well acquainted with the legal, normative and documentary requirements for the development and manufacture of medical devices in theory and practice. From many years of experience in technical project management, I know the practical problems and challenges involved in implementing a product idea into a marketable product.

My main focus as a consultant is the support and assistance in the chemical/technical implementation of the requirements according to MDR & IVDR. I am also happy to offer my competence and experience in the development and production of medical devices and in-vitro diagnostics.