LIVE VIRTUAL WORKSHOP
NEW GCP for Medical Devices, ISO 14155:2026: What You Need to Know
“ISO 14155:2026 is more than an update to the standard—it’s an opportunity to rethink how we design, conduct and oversee medical device clinical investigations.”– Mark-Flynn, Founder, Global Edge Medtech Consulting
“Yet another informative and interesting session. It gave me an excellent foundation of knowledge to further assist me in my role. I would recommend this workshop to researchers and students working in health and medical sciences with an interest in medical devices, HREC members and secretariats, and anyone involved with medical device related clinical trials. I always leave these sessions with a deeper understanding of the topic and the ways in which it will help me do my job.” – Alison Harwood, Human Research Ethics Officer, University of Adelaide
“This workshop was exactly what I needed. It reinforced and explained on things I already knew and opened my eyes to areas that I need to know more about. [The facilitator] was excellent, personable, authoritative and engaging. They provided plenty of practical examples and anecdotes from real world experience and I could see how my situation related to the GCP principles with the help of those “bridges to reality”. – Julia Wunderlich, Senior Clinical Research Fellow, Bionics Institute
Do you use medical devices in your research and/or clinical trials?
The TGA and overseas regulators have strict regulations for medical devices. Regulations continue to evolve as advances in technology increase the complexity of medical devices.
If your team is involved in medical device research, clinical trials, ethics review, governance, sponsorship, development or commercialisation, this updated workshop is for you.
It’s essential that you are familiar with the latest regulations – however, keeping up to date can be overwhelming.
GCP for Medical Devices ISO14155: 2026 is an expert-led workshop designed to provide you with valuable guidance on how to navigate the latest regulations and standards related to medical devices. By strengthening your knowledge of the latest standards and regulations, you can ensure your research with medical devices leads to excellent science and reduced risk.
You can claim 4 CPD points on completion of this Workshop.
PRAXIS GCP workshops and courses are Transcelerate endorsed and are practical, real world training to help research professionals strengthen compliance, build confidence and support ongoing inspection readiness in line with current TGA expectations and ICH E6 (R3).
Who is this workshop for?
- Staff using medical devices in research or clinical trials
- Clinical trial teams
- Sponsors and investigators
- HREC members, ethics staff and ethics teams
- Research governance staff
- MedTech startups, SMEs and industry teams
- CROs, quality, regulatory and project teams
- Anyone involved in medical device development, research or commercialisation
Learning Objectives
On completion of this workshop, participants will be able to:
- Explain the principles of Good Clinical Practice (GCP) for medical devices and the role of ISO 14155:2026.
- Understand the key updates introduced in ISO 14155:2026 and their practical implications.
- Apply Good Clinical Practice principles to the design and conduct of clinical investigations involving medical devices and Software as a Medical Device (SaMD).
- Apply risk-based thinking to the design, conduct and oversight of medical device clinical investigations.
- Understand how ISO 14155:2026 aligns with FDA, EU MDR, TGA and ISO 14971 requirements. Identify the essential.
- Identify the essential documentation required to initiate and manage a compliant medical device clinical investigation.
- Strengthen participant protection, data integrity and inspection readiness through the practical application of GCP.
- Develop a clinical evidence strategy to support regulatory approval, market access and commercialisation.
Medical device research is growing. Expectations are increasing. Make sure you and your team are ready.
Our training and education offers have been developed according to Australian and international best practice standards.
Our modules are built upon the competencies developed by the Harvard Multi-Regional Trials Centre (MRCT) and aligned to competencies recommended by the NHMRC.
These training offers are regarded as a benchmark for researchers, clinical trials, and healthcare professionals in Australia and internationally.
About the Facilitator
Dr Mark Flynn
Dr Mark Flynn is a highly experienced MedTech clinical leader and strategist, particularly in identifying and solving the wicked challenges in healthcare.
He has launched over 20 medical devices for millions of people globally. He is a clinical strategist who is adept at R&D and new product introduction into global markets. During his career he has worked and lived in Australia, Europe, USA, China, and Latin America.
Mark has held senior executive leadership positions at Cochlear Ltd, Demant A/S, and for medtech start-ups in Europe (e.g., Wise Neuro & IQORO) and Australia (e.g., Atmo Biosciences, Hemideina Pty Ltd).
Mark was awarded a PhD in Medicine (1998) from the University of Melbourne. In 2017 he was awarded dual MBAs from Georgetown University (USA) and ESADE School of Business and Law (Spain).
He has sponsored medical device clinical trials in Europe, USA, Latin America, Asia, and Australia, often complex multicentre studies for regulatory approval/clearance ad post market follow-up.
He has developed his strategy to deliver clinical trials meeting regulatory requirements while mixing in pragmatism to deliver marketing and reimbursement outcomes at the same time.
Price
Price: $599 +GST pp
PRAXIS Partner price: $479 +GST pp
*Savings available for group enrolments and for PRAXIS partner organisations.
Next Virtual Workshop
Wednesday 22 July 2026: 10.00am – 2.00pm (Sydney Time) Seats Going Fast
PRAXIS Australia has the right to cancel a workshop or training session (or move the event format online) due to unforeseen circumstances. For more information regarding our Cancellation Policy and your rights as a student, please see our Student Terms and Conditions document.
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