SERVICE
New GCP for Medical Devices | ISO 14155:2026 | Updated Courses
Are your medical device trials aligned with the latest GCP and ISO 14155:2026 updates?
“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
Medical device trials are different to drug trials
They bring different risks, regulatory considerations, evidence requirements and responsibilities for sponsors, investigators, trial teams, ethics committees and governance staff.
With ISO 14155:2026 now setting the current standard for Good Clinical Practice in medical device clinical investigations, it is important that your team is confident, current and prepared.
Medical device trials require more than general GCP training.
If your team is involved in medical device research, clinical trials, ethics review, governance, sponsorship, development or commercialisation, this updated online training pathway will help strengthen your understanding of device-specific GCP and ISO 14155:2026.
Updated online training pathway
The PRAXIS GCP for Medical Devices online training pathway includes two modules, designed to be completed in sequence.
Module 1 – C5.08: Overview of Medical Devices
This module provides the essential foundation for understanding medical device regulation.
Participants will explore what qualifies as a medical device, how devices are classified, how risk is managed, and how regulatory approval and clearance pathways operate in Australia and internationally.
Module 2 – C5.09: GCP for Medical Devices, ISO 14155:2026
This module builds on the foundation provided in C5.08 by focusing on Good Clinical Practice for medical device trials.
It explains how ISO 14155:2026 applies to the design and conduct of medical device clinical investigations, including documentation, data quality, adverse events, privacy, sponsor and investigator responsibilities, and trial suspension, termination and close out.
Why complete both modules?
Together, these modules provide a practical and current pathway for anyone working with medical devices in research or clinical trials.
C5.08 helps participants understand the regulatory context for medical devices.
C5.09 focuses on applying GCP and ISO 14155:2026 in practice.
Completing both modules supports safer, higher-quality and more compliant medical device research.
Who should complete this training?
This updated training pathway is ideal 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
Pricing
Each module is $198 + GST.
Participants may enrol in one module or complete both modules as the recommended pathway.
Medical device research is growing. Expectations are increasing. Make sure your team is ready.
Enrol in the updated PRAXIS GCP for Medical Devices online training pathway today.
Prefer live, expert-led training?
If you prefer live, interactive guidance, PRAXIS also offers a GCP for Medical Devices live virtual workshop.
This workshop is ideal for teams who want expert-led discussion, practical examples and the opportunity to ask questions about device-specific GCP, ISO 14155:2026 and the conduct of medical device clinical investigations
Suggestion box: new offers and interest areas
What would you like to see from us? This can be a topic we haven't covered yet, a course style, or a different way of delivering our courses and workshops. All suggestions are welcome and will be considered.