Strengthening Medical Device Regulatory Readiness at the Trials Accelerator – Institute for Clinical Trials in Galway
Practical ISO 14155 and EU MDR Training for Clinical Investigation Staff
To equip clinical and research staff with practical, decision-focused regulatory knowledge, the Trials Accelerator partnered with ECCRT to deliver a one-day, face-to-face training on ISO 14155, EU MDR 2017/745, and ICH-GCP E6(R3).
About the Organisation
The Trials Accelerator isupports the planning C design of biomedical research, and supports staff involved in medical device and clinical investigations. Continuous professional development ensures staff are equipped to conduct high-quality, compliant clinical research and manage the governance demands of clinical investigations involving medical devices.
Challenges and Objectives
While staff had strong clinical expertise, they required additional support to confidently navigate the regulatory and operational demands of medical device investigations, including:
- Guidance on applying ISO14155 and EU MDR in real-world clinical
- Knowledge to implement study classification, delegation of responsibilities, and risk-proportionate
The training aimed to help participants:
- Understand how medical device clinical investigations are structured, classified, and regulated across their lifecycle with a particular focus on early-phase
- Apply ISO14155 principles in planning, executing, and monitoring clinical
- Apply quality-by-design and risk-proportionate oversight principles to real-world study planning and oversight activities.
- Translate regulatory knowledge into actionable, day-to-day operational
ECCRT Approach
ECCRT delivered a tailored, one-day, face-to-face training designed specifically for research staff involved in medical device clinical investigations, featuring:
- Structured overview of EU MDR, ISO14155, and ICH-GCP E6(R3).
- Practical examples and case discussions linking regulations to clinical
- Interactive exercises and QCA to encourage applied
- Guidance on study classification, delegation of roles, and compliance
- Supporting course materials for post-training
The training was delivered in English by an experienced ECCRT trainer with hands-on experience in clinical research operations, regulatory compliance, and inspection-ready practices.
Participant Feedback and Impact
Participants praised the trainer for being knowledgeable, personable, and interactive, making complex regulatory concepts clear and immediately applicable.
Participant feedback:
- “The trainer’s practical examples and clear explanations made the course very engaging and useful.”
- “The interactive session helped me see how theory applies in our ”
- “I now have a better understanding of medical device lifecycle, study classification, and regulatory responsibilities.”
- “It helped translate complex regulatory frameworks into practical ”
Staff reported a strengthened understanding of the medical device lifecycle, ISO 14155, EU MDR, and ICH-GCP E6(R3), along with increased confidence in making risk-proportionate, quality-by-design decisions in their day-to-day roles.
Why Choose ECCRT?
ECCRT delivers tailored, practical training that helps clinical and research teams translate complex regulatory requirements into confident, day-to-day operational decisions. With expert trainers, interactive delivery, and a strong focus on real-world application, ECCRT supports organisations in building sustainable regulatory competence for medical device clinical investigations.