We are proud that our network of trainers continues to grow. We are delighted to introduce you to all of our experts.

They all have one thing in common: many years of experience in their specialty. They focus on providing practical, implementation-oriented tips in addition to sound theoretical input in their training courses.

Dipl.-Ing. Martin Schmid

Training topics:

  • ISO 13485:2016 – Quality management for medical devices & IVDs
  • ISO 13485:2016 – Practical training for internal audits
  • Technical documentation according to MDR / IVDR
  • General safety and performance requirements for active medical devices
  • Requirements & processes for the development of medical devices & IVDs
  • ISO 14971:2019 – Risk management for medical devices & IVDs
  • Post-market surveillance: Post Market Surveillance
  • Medical Software EN 62304
  • and much more.

Founder, Managing Director and Senior Consultant at en.co.tec, for many years a trainer at en.co.tec seminars and en.co.tec in-house training courses, at several universities of applied sciences and in cooperation with Austrian and German life science clusters. For more than 20 years, he has been supporting a wide range of medical device and IVD companies in the introduction of risk management and quality management systems and accompanying product approvals.

What is important to me / How I can support you with my knowledge:

When I founded en.co.tec, I wanted to help other medical device companies with my 10 years of industry experience in development, approval and quality management to recognize the stumbling blocks and pitfalls in good time and thus save a lot of time and money.

Today, 20 years later, I would like to pass on this knowledge in my seminars. To help you understand what really matters, I want to enable you to maintain an overview of a complex regulatory landscape. What drives me is to help you understand and implement the various regulatory requirements in order to be successful as a medical device manufacturer on the market.

My background:

As a technician from an early age, studying electrical engineering was foreseeable. My diploma thesis took me into the world of medical devices. It was already clear then that mastering the regulatory requirements (in addition to excellent technology) was the key to success.

The fact that all European directives and standards – some of which are now in their third edition – were in the process of being developed only becomes clear today in retrospect. This gave me the unique opportunity to experience this entire, dynamic process of establishing the European system of regulatory requirements for medical devices from the very beginning and in some cases (e.g. with regard to risk management) even to help shape it.

I am a member of standardization committees, lecturer at universities and technical colleges, speaker at international congresses, author of internationally acclaimed publications, etc.

My core competencies:

  • Regulations: Regulatory requirements for medical devices and in-vitro diagnostics. (MDD, IVDD, MDR, IVDR, ISO 13485, ISO 14971, plus the applicable MEDDEV and MDCG guidelines)
  • Consulting processes: Internal audits, mock audits, gap analyses, implementation of quality and risk management systems.
  • Products: Active medical devices (incl. software), material medical devices, in-vitro diagnostics

DI Gabriele Ettenberger

Training topics:

  • EN 10993 – Biocompatibility of medical devices
  • General safety and performance requirements for non-active medical devices

Long-standing expert in material applications and material testing for pharmaceuticals, medical devices and hygiene as well as 25 years of experience in the development and testing of medical devices at OFI, Vienna. Advice and support for national and international medical device manufacturers in the areas of biocompatibility, cleaning validation, storage stability, extractables & leachables, risk assessments, selection of materials and reprocessing of medical devices. In-house training courses and innovation workshops, trainer for adult education and mentoring.

What is important to me / How I can support you with my knowledge:

As a qualified adult education trainer and knowledge manager, I believe that the success of knowledge acquisition depends on close cooperation between the trainer and the “learner”. For me, simply imparting information is not enough to build competence in the “learner”. It is therefore very important to me that the “learner” can link new information with existing knowledge and experience. The learning units therefore also include practical examples and at least one exercise unit. This participative and highly motivating approach allows the desired competence to be developed in a targeted manner in the training units.

My background:

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

Education

  • Studied food and biotechnology at the University of Natural Resources and Life Sciences, Vienna
  • Studied personnel and knowledge management at the FH, WKO, Vienna
  • Trainer for adult education at the WKO
  • Project management: IPMA Level B certification, 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 users, Art of Hosting (AoH)

My core competencies:

Advice and support for national and international medical device manufacturers in the areas of biocompatibility, cleaning validation, storage stability, mechanical resilience, extractables & leachables, risk assessments, selection of materials, reprocessing of medical devices and hygiene (surface and air hygiene).

Marie Salin

Training topics:

  • EU regulation for in-vitro diagnostics (IVDR): Implementation for manufacturers
  • EU regulation for in-vitro diagnostics (IVDR): Implementation in the routine laboratory and handling in-house methods
  • Technical documentation according to IVDR
  • The path to laboratory accreditation in accordance with EN ISO 15189:2012
  • General safety and performance requirements according to IVDR

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

What is important to me / How I can support you with my knowledge:

After many years of experience with manufacturers of in-vitro diagnostics, I am pleased to be able to pass on my knowledge and experience to you.

What do you need to pay particular attention to, what can you do quickly and how do you systematically get through all the requirements to your goal? For practice from practice!

My background:

I am a lawyer trained in France and Austria with a focus on quality management, medical device law and certification of quality management systems.

I have currently been Managing Director of West Medica Produktions- und Handels-GmbH for almost 20 years – and a consultant at Salin Consulting.

My core competencies:

  • R&D / Research IVD Products
  • Internal auditor for QMS (ISO 9001:2015, ISO 13485:2016, ISO 15189:2012)
  • Commercial managing director for the manufacture of medical devices
  • Advice and support for IVD / QMS / medical devices

Priv. Doz. Dr. Ghazaleh Gouya Lechner

Training topics:

  • Clinical testing & evaluation of medical devices according to MDR
  • Clinical performance evaluation & testing of in-vitro diagnostics according to IVDR

Medical and scientific expert and owner of Gouya Insights KG, an expert consultancy for medical device and biotechnology companies for the strategy, planning and execution of clinical trials and clinical evaluations;

What is important to me / 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 proving the performance and safety of a product.

Knowledge of the study design, study population and time points of the endpoints is essential in order to interpret data from your own clinical trial or to understand and interpret data from competitor clinical trials and to use them for clinical evaluation.

With over 20 years of medical and scientific expertise in clinical research, I would like to make my knowledge and experience available to researchers and manufacturers in MedTech.

My background:

Specialist in internal medicine, cardiology and clinical pharmacology.

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.

Lecturer at the Medical University of Vienna for several years, also in the Master’s program “Clinical Trials”.

My core competencies:

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

Poppy Abeto Kiesse, MSc.

Training topics:

  • EUDAMED – Registration of UDI and devices
  • Labeling and UDI marking of medical devices and in-vitro diagnostics

Business Development Manager at GS1 Austria GmbH. In this role, she supports projects, companies and organizations in the implementation of logistics and communication standards to increase the traceability of e.g. medical products and pharmaceuticals within the value chain and to meet regulatory requirements worldwide.

Training and further education with a focus on medical informatics:

  • MSc. in Healthcare and Rehabilitation Technology / Technikum Wien
  • BSc. in Biomedical Engineering / Technikum Wien

Further skills/experience in the areas of:

  • Radiation protection, laser protection,
  • Export/import of medical devices,
  • Real estate and construction projects in the healthcare sector

Daniel Rubisoier BSc, MSc

Training topics:

  • EU Medical Device Regulation (MDR) – basic course
  • Responsible person according to MDR / IVDR

Conformity Assessment Procedure Specialist MDR, TÜV SÜD Product Service GmbH

Thanks to my many years of expertise in the field of regulatory affairs and quality management of medical devices with various manufacturers and the notified body, I am happy to pass on my knowledge and experience to beginners and professionals alike.

Regulation (EU) 2017/745 is part of my daily work. I am happy to help you understand and positively implement the EU Medical Device Regulation (MDR) in order to ultimately provide compliant medical devices on the market and to monitor these medical devices on the market.

Dipl.-Inf. (FH) Michael Engler

Training topics:

  • Requirements Engineering
  • Usability Engineering

Many years of experience as a consultant in the medical technology sector. He shares his extensive specialist knowledge in numerous publications, e.g. TÜV Rheinland. He is a lecturer at the University of Applied Sciences Upper Austria for the Master’s program in Medical Technology on the topics of usability engineering and requirements engineering. He holds seminars on medical software and usability engineering for medical products for TÜV Rheinland.

Günter Rodenkirchen

Training topic:

  • Software for QM processes with a focus on medical technology (MDR, ISO 13485)

What is important to me / How I can support you with my knowledge:

Digitizing a QM system is much more than just using WORD and PDF files on file servers or managing complaints in an EXCEL spreadsheet. An eQMS must be considered holistically; it is a business-critical management system. It has connections to all important systems in the company, ERP, LIMS, PPS, etc.

But above all, a holistic eQMS brings major changes to the way a company handles documents and processes. It is important to me that companies recognize and use the opportunities presented by the change to ensure and improve their quality. That they gain more transparency and become faster in their processes.

My background:

At my age, I’m still a typical career changer. Born in 1956 and starting my professional life in 1972 with a commercial apprenticeship, I worked in this environment until 1988. My first contact with IT (not yet IT at the time) and the first personal computers quickly inspired me. Not only from a technical point of view, but above all the potential for improving and optimizing operational processes. First in the CRM area, then later in the DMS environment. I discovered the regulated pharmaceutical and medical technology sector in 2008. Here I was able to gain experience in regulatory affairs, submission management and pharmacovigilance. Since 2013, I have been involved in the planning and implementation of software for QM systems in this industry.

My core competencies:

  • Capture and understand processes quickly
  • Supporter of the CIP concept (self-proclaimed change junkie)
  • Communicating digitization potential
  • High level of competence in dealing with heterogeneous project groups

DI (FH) Michael Ring

Training topics:

  • Overview of MPG and MDR for beginners
  • Clinical evaluation of medical devices
  • Performance evaluation of IVD

Head of Regulatory Affairs at CADS GmbH, consultant and trainer, many years of experience in the planning and implementation of clinical trials, manager of clinical trials at Kepler University Hospital (eye clinic), trainer at Quality Austria.

What is important to me / How I can support you with my knowledge:

I interpret my role as a consultant as long-term support for companies in the implementation of ideas in the fascinating field of medical technology. I am happy to use my broad specialist knowledge and my professional network to help companies overcome the many challenges in this field.

My professional passion is in particular 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, I support companies in the medical technology 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 founded Kepler University Hospital in Linz from 2014 to 2019. My tasks included the coordination of clinical studies.

My core competencies:

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

DI Andreas Parzer

Training topics:

  • EN 60601-1 medical electrical equipment
  • Medical Device Operator Ordinance

More than 25 years of professional management of the accredited test laboratory of TÜV AUSTRIA for medical electrical devices 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 the WIFI St. Pölten and at the 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 devices and QM systems for medical devices. Member of the OVE Technical Standards Committee for Medical Devices and the international working group IEC SC62A / WG 14, which deals with the IEC 60601-1 standard.

What is important to me / How I can support you with my knowledge:

  • Imparting knowledge on the approval of medical devices
  • Illustration of the problems and sensitization before entering the medical device industry
  • Explanation and communication of the need to comply with standard requirements

My background:

  • More than 30 years of experience in testing medical electrical devices and laboratory equipment
  • Many years of professional management of an accredited test center for medical electrical devices and laboratory equipment
  • Participation in international testing 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 during development
  • Advice on requirements for accredited testing and inspection bodies
  • Auditing activities (EN ISO 9001, EN ISO 13485, MDD)
  • Speaker activities (EN 60601 series of standards, EN ISO 13485), in-house training courses

Prof. Dr. Max Singh, Professor of Medical Technology, OTH Regensburg

Training topics:

  • Regulation (EU) 2017/745 on medical devices (MDR)
  • Responsible person according to Article 15 MDR/IVDR (PRRC)
  • Medical device consultant
  • Design Control
  • Risk management according to ISO 14971
  • Technical documentation according to MDR Annex II & III
  • PMS & PMCF

My background:

I have been teaching and researching as a professor of medical technology at OTH Regensburg since 2021. Before that, I worked in the medical device industry for many years and took on a variety of tasks along the value chain, especially in R&D and product management at manufacturers. After my industrial career, I moved to the Notified Body TÜV SÜD, where I worked in business field development, including onboarding new customers with high-risk products.

A central focus of my work was also the training of product experts and auditors in the area of Regulation (EU) 2017/745 on medical devices (MDR).

As a freelance speaker and consultant, I have been offering numerous training courses on product development and regulatory requirements since 2021. I moderate interactive seminars, bring in practical examples and promote exchange through lively discussions to ensure a sustainable transfer of knowledge.

Education:

Dipl.-Ing. (FH) Medical Engineering, MBA, PhD in Innovation & Entrepreneurship

DI (FH) Helmine Trinkl

Training topic:

  • ISO 9001 – Overview and implementation

Managing Director Trinkl Unternehmensfit,

Management consultant with more than 30 years of consulting experience for companies of all sizes.

Many years of experience as a coach and trainer for in-house training courses and TÜV Austria Academy seminars, TÜV Cert. Auditor

Thomas van den Oever

Training topic:

  • MDSAP – Medical Device Single Audit Program

Independent service provider with around 20 years of experience in the field of medical technology

My topics are the introduction and optimization of quality management systems with a focus on:

  • GAP analysis against ISO 9001, ISO 13485, MDR, IVDR, MDSAP, FDA
  • Internal audits, supplier audits, due diligence
  • Setting up plans to close the GAPs
  • Implementation or support for remediation projects
  • Preparing for and accompanying external audits/inspections (several times for MDD, MDR, IVDD, but also according to MDSAP and FDA)
  • Interim management at 2nd level (already implemented with up to 120 employees: production management, QM management, QC management, QA management)
  • Closure and transfer of locations in a regulated environment
  • Lean management in a regulated environment
  • EU PRRC

Dr. Cornelia Luban

Training topic:

  • Approval of medical devices in the USA
  • Quality Systems Regulation of the USA

Senior Consultant and Trainer at Qserve Group Deutschland GmbH

International experience in the approval and quality management of active and non-active medical devices including software as a medical device.

Dr. Cornelia Luban has many years of experience in a strictly regulated field. She is Lead Auditor and Quality & Regulatory Affairs Manager.

DI Robert Maczejka

Training topics:

  • Internationalization of medical devices
  • MDR Chanc(g)es
Owner of the consulting company QROC – Quality Management, Regulatory Affairs, Organizational Development & Change for Medical Devices & InVitro Diagnostics.
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 and targeted communication

Dr. Markus Wagner

Training topics:

  • Functional safety for medical devices
  • CE conformity assessment procedure MDR
  • Quality management according to ISO 13485 and MDR
  • Classification of medical software
  • Software life cycle, risk management
My background:
  • Professional activity:
    • Long-standing employee at the notified body TÜV SÜD Product Service GmbH
      Implementation of conformity assessment procedures for medical devices according to MDD and MDR
      Auditing of medical device manufacturers according to ISO 9001, ISO 13485, MDD, MDR
  • Education:

    • Degree in electrical engineering
    • Doctorate in the field of coding theory, memory protection methods

Nilaykumar Patel MSc.

Training topic:

  • Cybersecurity

My background:

Multilingual life science professional with more than 12 years of international experience

My core competencies:

  • Quality & Regulatory Affairs
  • Project management
  • Policy-Making
  • Strategic Planning & Business Development
  • Preclinical research
  • Sport & Team Management

Education

  • BSc. biomedical engineer
  • MSc. Molecular Biotechnologist – graduated with distinction
    Regulatory & Quality Expert
  • TüV Austria Academy certified & experienced quality auditor

Specialized on 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

Dr. Ingrid Jez

Lawyer for medical law

Training topic:

  • LAW at a glance: AI competence according to the AI Regulation (AI Act of the EU)

My background:

My core competencies:

Education: