In the rapidly evolving Medtech landscape, compliance alone is no longer enough. True excellence requires organisations to go beyond meeting regulatory expectations. It demands a proactive, structured approach to identifying, assessing, and controlling risk across the entire product lifecycle.
At Trinzo, we help life sciences organisations strengthen their risk management frameworks to protect patients, improve product quality, and ensure market success. Drawing on our extensive experience in regulatory, quality, and remediation consulting, we are proud to partner with Irish Medtech Skillnet to deliver ISO 14971 in Action: Proactive Risk Management for MedTech – a practical, accredited training programme designed specifically for professionals working in the sector.
Why Proactive Risk Management Matters
For medical device manufacturers, risk management is the backbone of both compliance and quality. ISO 14971:2019 – the international standard for risk management of medical devices – is not just a regulatory requirement under the MDR, IVDR, and FDA frameworks; it is the foundation for sustainable performance and patient safety.
A reactive approach to risk is costly and short-sighted. Recalls, warning letters, and loss of market access often stem from weak or inconsistent risk management processes. By contrast, a proactive approach enables organisations to foresee challenges, reduce failure points early in development, and maintain compliance as regulations evolve.
Effective risk management is not simply a checkbox exercise. It is a culture – one that integrates technical understanding, process control, and continuous improvement. At Trinzo, we have seen first-hand how building proactive risk capability transforms not only compliance performance but also operational resilience.
About the Training Programme
ISO 14971 in Action: Proactive Risk Management for MedTech is an intensive four-session online course, and turns the principles of ISO 14971 into practice. Participants gain hands-on experience in identifying hazards, assessing risks, and implementing control measures across every phase of the medical device lifecycle.
This accredited programme, led by industry experts, aligns with the requirements of ISO 14971:2019 and ISO/TR 24971, providing an in-depth understanding of how to apply risk management effectively within real-world scenarios. The training is highly interactive and supported by practical tools, templates, and case-based exercises.
Key topics include:
- The full risk management process – from hazard identification to risk evaluation and control
- Understanding biocompatibility (EN ISO 10993) and electrical safety (60601/61010 series)
- Creating and maintaining compliant risk files and documentation
- Fundamentals of combination product risk management
- How to integrate risk-based thinking across R&D, Quality, and Regulatory functions
Participants leave the course with a clear roadmap for implementing ISO 14971 effectively and develop the confidence to apply its principles in daily decision-making.
Who Should Attend
This programme is designed for professionals across the Medtech ecosystem, including:
- R&D teams integrating risk management into product design and innovation
- Quality and Regulatory specialists ensuring alignment with ISO 14971, FDA, MDR, and IVDR requirements
- Operations and Supply Chain professionals identifying and mitigating process and supplier risks
- Clinical and Post-Market Surveillance teams evaluating risks in real-world product performance
- Business and Leadership roles seeking to embed a culture of risk awareness and data-driven decision-making
Whether you are developing a new medical device, maintaining compliance for an existing product line, or managing a complex supply chain, this training equips you with the tools and mindset to stay ahead of regulatory challenges.
Join Us
The upcoming sessions will take place on:
Tuesday 20th, Wednesday 21st, Tuesday 27th, and Wednesday 28th January 2026 (1:00 PM – 5:00 PM).
Standard rate: €1,975 | Subsidised rate: €1,285 | SME subsidised rate: €540 (contact us)
Spaces are limited, and early registration is recommended.
Take the next step in strengthening your compliance and quality systems. Join Trinzo and Irish Medtech Skillnet for this essential training and gain the expertise to make proactive risk management a competitive advantage in your organisation.
👉 Register Now for ISO 14971 in Action: Proactive Risk Management for MedTech: https://www.irishmedtechskillnet.ie/course-detail/iso-14971-in-action-proactive-risk-management-for-medtech/?id=71