Our trainers

 

Martin Schmid zugeschnitten 150xpixDipl.-Ing. Martin Schmid

Training topics: ISO 13485, Medical Device Development & CE Marking, Medical Software EN 62304, Risk Management ISO 14971

Managing Director and Senior Consultant of en.co.tec Schmid KG. Trainer at en.co.tec medical technology seminars and en.co.tec in-house trainings, at the Universities of Applied Sciences of Upper Austria and Wiener Neustadt, at the Danube University Krems, at Austrian-Standards-plus trainings and all Austrian medical technology clusters since many years. For more than 15 years, he has supported a wide variety of medical technology companies in the introduction of risk management and quality management systems and accompanied product approvals.


MR i.R. Hon (FH) Prof. Dr. Wolfgang Ecker

Training Topic: The new EU Regulations for Medical Devices & IVDs

Ministerial councilor i.R., negotiator of the new regulations in the EU Council, long-time Head of Department III/3 “Medicinal Products and Medical Devices” at the Federal Ministry of Health, Vienna.

How I can support you with my knowledge:

MDR and IVDR require the manufacturer to follow a clear regulatory path under their QMS that takes him/her from an initial product idea, through safety and performance requirements, to Euro-approval, and on to a solid stay on the market. For this, I offer my first-hand expertise. You should always have a reliable GPS at your disposal. In this way, I can help you avoid costly wrong decisions and detours. You will then know exactly what the new regulations require and how to comply with them using EU guidelines and standards, and how to negotiate on an equal footing with notified bodies and competent authorities. It is important to me that you can bring safe and effective medical devices/IVDs to market with confidence.

My background:

I am a medical doctor by training and have more than 30 years of experience in the Ministry of Health (Head of Department for Medicinal Products and Medical Devices) and in the relevant EU committees. I have been very actively involved in the MPG and the new EU regulations MDR and IVDR and in many EU guidelines. Among other things, I was a member and chairman of the EU working group CIE Clinical Investigation and Evaluation for many years and also participated in the global GHTF-AG Clinical Evidence in this area. Currently, I lecture at universities of applied sciences for medical technology in Linz and biomedical engineering in Vienna, hold seminars for the Austrian medical technology clusters and work on European and global medical device and IVD standardization in Committee 179 of the Austrian Standards Institute. Author of standard works on the new EU regulations for medical devices and IVDs.

My core competencies:

Regulatory know-how for medical devices and IVD in Europe and nationally (co-designer!), from delimitation issues to technical and preclinical evaluation and clinical evaluation of MP (or analytical and clinical performance evaluation of IVD) to European Conformity Assessment to Post Market Surveillance System and Vigilance System and European Registration.

Absolute favorite areas: Clinical evaluation and testing of medical devices; performance evaluation and performance studies of IVD.


JöbstlEwald Jöbstl

Training topics: ISO 13485, FDA, MPG

Consultant & Trainer at en.co.tec, has international experience in quality management, project management and development of high-tech measuring instruments. In the quality management sector, Mr. Jöbstl has many years of experience in a highly regulated field. He is a certified auditor, Quality & Regulatory Affairs Manager, System Manager Quality and trainer for adult education.


Festi

Ing. Wolfgang Festi

Training topics: ISO 13485, Audits

Trainer and auditor for more than 20 years, among others at Quality Austria. More than 1000 audits based on the following standards: ISO 9001, ISO 14001, EN 46001, ISO 13485, mostly as responsible audit manager in Austria and abroad. Consultancy and support of more than 60 companies in setting up and implementing management systems, more than 200 courses and trainings conducted.


 

DI (FH) Helmine Trinkl, Geschäftsführerin Trinkl Unternehmensfit

Training topics: ISO 9001

Management consultant with more than 20 years of consulting experience for companies of various sizes. Many years of experience as a coach and trainer in in-house training courses and TÜV Austria Academy seminars.


Dipl.-Inf. (FH) Michael Engler

Training topics: Requirements Engineering, Usability Engineering

Many years of experience as a consultant in the medical technology industry. He shares his extensive expertise in numerous publications, e.g. TÜV Rheinland. He is a lecturer at the Upper Austria University of Applied Sciences for the Master’s degree program in medical technology on the topics of usability engineering and requirements engineering. For TÜV Rheinland he holds seminars on topics of medical software and usability engineering for medical devices.


DI (FH) Michael Ring

Training topics: Clinical evaluation of medical devices, performance evaluation of IVDs

Managing Director at RnB Medical Software Consulting GmbH, consultant and trainer, many years of experience in planning and conducting clinical studies, manager of clinical studies at Kepler University Hospital (Eye Clinic), trainer at Quality Austria, lecturer at Upper Austria University of Applied Sciences, field of study Medical Technology – Software Lifecycle Processes.

How I can support you with my knowledge:

I interpret my role as a consultant as a long-term support of companies in the implementation of ideas in the fascinating field of medical technology. I am happy to offer my broad expertise and my professional network in order to jointly master the diverse challenges of this field. My professional passion especially is the topic of clinical evaluation of medical devices.

My background:

I am co-founder of R’n’B Consulting GmbH and co-founder and consultant of the Competence Center for Medical Devices GmbH (CCMD). Together with my business and cooperation partners, it supports companies in the medical device industry in the compliant implementation of the clinical evaluation process, including the conduct of clinical trials and systematic literature searches.

I also worked as a study coordinator at the newly established Kepler University Hospital in Linz from 2014 to 2019. My responsibilities included the coordination of clinical trials.

My Core Competencies:

My core competencies include planning and conducting clinical evaluations of medical devices. This context includes systematic literature searches and the planning of clinical trials.


Dr. Benjamin Reutterer

Training topics: Clinical evaluation of medical devices, IVDR

Clinical trials expert and former en.co.tec consultant; immunobiologist, many years of experience in industrial research and development of drugs and medical devices, as well as in planning and conducting clinical trials with drugs and medical devices.


Leo Heilinger

Training Topics: Start-Up Workshop, Medical Device Sales and Marketing, International Sales.

Management and organizational consultant for medical device companies. Many years of international experience in management and marketing, sales, business development for medical devices. Accredited export consultant at WKO – incite. “Expert of Residence” at INiTS-Universitäres Gründerservice Wien GmbH with focus on startup consulting, medical technology and medical laboratory diagnostics, medical informatics, marketing and sales for national and international markets. Guest lecturer at the FH Steyr for medical device marketing.


DI Andreas Parzer

Training topics: EN 60601-1 medical electrical equipment

More than 25 years technical management of the accredited test laboratory of TÜV AUSTRIA for medical electrical equipment and medical laboratory equipment, lead auditor for QM standards EN ISO 9001 and EN ISO 13485, auditor for MDD. Trainer for many years at en.co.tec medical technology seminars and en.co.etc in-house training courses, at WIFI St. Pölten and at TÜV Austria Academy for the standards EN 60601-1, EN 60601-1-x, EN 60601-2-x and EN 80601-2-x. Trainer for in-house training courses on standards for medical electrical equipment and QM systems for medical devices. Member of the OVE Technical Standards Committee Medical Devices and the international working group IEC SC62A / WG 14, which deals with the standard IEC 60601-1-.

How I can support you with my knowledge:

  • Imparting knowledge about the approval of medical devices
  • Illustrating the issues and raising awareness before entering the medical device industry
  • Explaining and communicating the need for compliance with standard requirements

My background:

  • More than 30 years of experience in testing medical electrical equipment and laboratory devices
  • Many years of professional management of an accredited testing laboratory for medical electrical devices and laboratory equipment
  • Participation in international test procedures (CB Scheme
  • Member of the international working group IEC SC62A / WG14 (IEC 60601-1)
  • Auditor and certification officer in former notified body
  • Lead auditor for EN ISO 13485
  • Speaker for encotec, WIFI Lower Austria, TÜV AUSTRIA Academy,…

My core competencies:

  • Testing of medical electrical devices and laboratory equipment
  • Tests accompanying development
  • Consulting on requirements for accredited testing and inspection bodies
  • Auditor activity (EN ISO 9001, EN ISO 13485, MDD)
  • Lecturer activity (EN 60601 series of standards, EN ISO 13485), in-house training courses

DI Gabriele Ettenberger

Training topics: EN 10993 – Biocompatibility of medical devices.

Expert of many years in material applications and material testing for pharma, medical devices and hygiene as well as 25 years of experience in development and testing of medical devices at OFI, Vienna. Consulting and support of national and international medical device manufacturers in the field of biocompatibility, cleaning validation, storage stabilities, extractables & leachables, risk assessments, selection of materials as well as reprocessing of medical devices. In-house training as well as innovation workshops, trainer for adult education as well as mentoring.

How I can support you with my knowledge:

As a trained trainer in adult education and knowledge manager, I see the success of a knowledge acquisition through the close cooperation between trainer and the “learner”. The mere imparting of information is for me too little to be able to build up competence in the “learners”. Therefore, it is very important to me that the “learner” can link new information with existing knowledge and his experiences. Therefore, the learning units also include practical examples and at least one exercise unit. This participative and very motivating approach allows to build up the desired competence in a targeted way in the training units.

My background:

Professional activity: long-time expert in material applications and material testing for pharma, medical devices and hygiene as well as 25 years of experience in research, development and testing of medical devices at OFI, Vienna.

Education:

  • Studies in food and biotechnology at the University of Natural Resources and Applied Life Sciences, Vienna.
  • Study of human resources and knowledge management at the FH, WKO, Vienna
  • Trainer for adult education at the WKO
  • Project Management: Certification IPMA Level B, Senior Project Manager, zSPM
  • Agile project management
  • Innovation Management: Many years of experience in holding innovation workshops as well as workshops on Open Innovation, Stakeholder Integration, Lead User, Art of Hosting (AoH)

DI Annette Hexelschneider

Training topics: ISO 9001:2015 – Knowledge of the organization, knowledge management

Lecturer, trainer, 18 years of experience in knowledge management in and with national and international organizations and companies in Germany, Austria and beyond. Many years of experience as a trainer in various industries and as a lecturer (FHs) in BA and Master courses. Among other things, trainer for the training to become a certified knowledge manager at the TÜV Austria Academy.

How I can support you with my knowledge:

I provide you with know-how, for the effective handling of knowledge in your company. If necessary, this includes meeting the requirements of standards. For this I convey to you ready-to-implement basics and easy-to-implement strategies as well as methods for the documentation, expansion and transfer of specialized knowledge.

My background:

I am a graduate engineer and bring many years of practical experience in preparation, transfer and management of expertise in various industries, in Germany, Austria and beyond. I am involved in projects, give seminars and workshops, and teach in several universities of applied sciences (BA, Master) in Austria. I also train certified knowledge managers at the TÜV Austria Academy.

My core competencies:

  • Didactic reduction: filtering out relevant expertise from complex knowledge structures in a goal-oriented manner.
  • Visual communication of data and complex expertise: Being seen, understood and remembered.
  • Knowledge transfer and knowledge management: Learning from each other in an easily usable way.
  • Creative problem solving: Exploring challenges, finding solutions and implementing them.

DI Sarah Lechner

Training topic: MDR: Responsible person for regulatory compliance.

How do I place a medical device on the market? What are my responsibilities as a Responsible Person? How do I plan for long-term compliance with these requirements?

Thanks to my education, experience with medical device start-ups in different growth phases and specific knowledge on active medical devices (class IIa/IIb), software development and IVDs (self-testing), I offer best practice examples and tips for implementation and help you answer these questions. Especially in the areas of regulatory affairs and quality management, I look forward to discussing with you the requirements up to and beyond marketing. With my knowledge I support you to get a better understanding of the current situation, prepare you for the role as a future responsible person and demonstrably meet its requirements.


Priv. Doz. Dr. Ghazaleh Gouya Lechner

Training Topic: Clinical Testing & Evaluation of Medical Devices

Medical and scientific expert and owner of Gouya Insights KG, an expert consulting company for medical devices and biotechnology companies for the strategy, planning and execution of clinical trials and clinical evaluations; lecturer at the Medical University of Vienna for several years also in the Masterprogram “Clinical Trials”; specialist in internal medicine, cardiology and clinical pharmacology, was Medical Director of a large contract research organization and is habilitated in internal medicine at the Medical University of Vienna since 2015.

How I can support you with my knowledge:

Understanding the clinical research of a medical device and the resulting interpretation of results. The planning of a clinical trial is the first and most important basis for providing evidence of the performance and safety of a product. In order to interpret data from one’s own clinical trial, or to understand, interpret and use data from competitor clinical trials for clinical evaluation, knowledge of study design, study population, timing of endpoints is essential. With over 20 years of medical and scientific expertise in clinical research, I would like to share my knowledge and experience to illuminate the path of clinical evaluation to researchers, manufacturers in MedTech.

My background:

Specialist in Internal Medicine, Cardiology and Clinical Pharmacology. For over 20 years in clinical research as Sub- and Principal Investigator, Sponsor and Medical Director in a large CRO (contract research organization) and now head of a boutique CRO specialized in clinical research of MedTech products.

My core competencies:

  • Development of a clinical development strategy
  • Capture of the clinical evaluation plan
  • Development of study protocols,
  • Submission of study protocols and essential documents to ethics committees, and regulatory authorities
  • Monitoring and risk management of clinical trials
  • Study design of pre- and post-market follow-up studies
  • Medical Device Vigilance
  • Data management
  • Biostatistics
  • Medical Writing
  • Development of the clinical evaluation report

DI Robert Maczejka

Training topic: Internationalization of medical devices, MDR Chanc(g)es

Owner of the consulting company QROC – Quality Management, Regulatory Affairs, Organizational Development & Change. Many years of experience in international regulatory affairs and quality management (strategy, internationalization, harmonization; cooperation with international authorities such as FDA, ANVISA, …), development and management of a global organization (including experience with quality initiatives, due diligence, M&As, investor onboardings, business reporting, budgeting) in an international company, training and practical experience in coaching, organizational development and intercultural as well as targeted communication.


Mag. Marie Salin

Training topic: IVDR basic course, IVDR in-house seminars

Managing Director, West Medica Produktions- und Handels-GmbH – experienced regulatory expert for IVD, consultant, trainer and certified internal auditor.

After many years of experience with a manufacturer of in-vitro diagnostics, I am pleased to share my knowledge and experience with you. What do you have to pay special attention to, what can you do quickly and how do you systematically get through all requirements to your goal?