Our team combines highly qualified expertise from outstanding education and training with relevant experience gained over many years in the industry. We take a customer-oriented approach to planning and implementing consulting projects and training sessions.

Dipl.- Ing. Martin Schmid
Managing Director & Senior-Consultant
martin.schmid@encotec.at

Education/ Experience
Degree in electrical engineering and many years of industrial experience in the medical technology sector as Head of Technology and Quality Manager, Managing Director of en.co.tec KG since 2000.

For many years trainer and consulting expert at en.co.tec and lecturer at universities and technical colleges and co-designer of postgraduate academic courses.

Co-initiator of innovative offers for the medical device community such as the Expert Consultation Hour and the Online Forum in cooperation with Austrian and German life science clusters and co-organizer of the Austrian Regulatory Conference.

For more than 20 years, he has been supporting a wide range of medical device and IVD companies in the introduction and auditing of quality management systems and accompanying medical device approvals.

Professional skills
Regulatory affairs according to the EU regulations MDR/IVDR and quality management systems especially for manufacturers and suppliers of medical devices (focus on active medical devices and software as well as material medical devices) and in-vitro diagnostics. Regulations and standards: EU regulations MDR/IVDR, ISO 13485, MDSAP, ISO 14971, IEC 62304.

Maga. (FH) Christa Bachinger-Hauk
Authorized signatory
Head of Marketing & Academy
christa.bachinger@encotec.at

Education / Experience
Degree in Marketing & Sales. Many years of industry experience in marketing and product management.

Professionel skills
Strategic & operative marketing, management of the academy, sales and customer care, cooperations, networking, controlling

Nilaykumar Patel MSc. MBA
Lead Auditor & Expert in Quality & Regulatory

  • Multilingual life science professional with more than 12 years of international experience in quality & regulatory affairs, project management, policy making, strategic planning & business development, preclinical research and sports & team management
  • BSc. Biomedical Engineer and MSc. Molecular Biotechnologist, graduated with honors and MAS of Health Tech Management
  • Regulatory & Quality Expert and TüV Austria Academy certified & experienced quality auditor
  • Specialized in the market launch of AI/ML-based software as a medical device
  • Know-how for the implementation of ISO 13485, ISO 14971, IEC 62366, IEC 62304 & 82304-1, GDPR, Medical Device Cybersecurity Requirements as well as FDA 21 CFR 820 & MDR (EU) 2017/745

Hedda Niederl
Seminar Organization and Office Management
hedda.niederl@encotec.at

Education/Experience
Tourism clerk with broad experience in customer service, employee qualification and catering management, organizational talent!

Fields of work: Seminar organization, office management;

 

Maga. Andrea Pierus M.A.
Marketing / Continuing Education
andrea.pierus@encotec.at

Education / Experience
Studied education and special and remedial education, specializing in medicine and studying adult education, additional training in psychology.

Fields of work
Teaching and experience in organizational development in the non-profit sector.