Introduction to medical device regulations, standards & technology adoption
This course is intended is to develop practical skills to help navigate prevailing medical device regulatory frameworks, via the use of international standards, coupled with an understanding of UK NHS healthcare technology management requirements. The course promotes a systems engineering approach equipping attendees to develop a blueprint that will integrate regulatory requirements, together with technology adoption and life cycle management factors. This approach is designed to reduce the time to market and increase the likelihood of clinical uptake.
The course delivery model is a virtual half day session covering the following topics:
- Systems Approach - conceptual model introduction
- Introducing medical device regulatory frameworks
- Key international standards - overview & navigation
- Risk management using ISO 14971
- Quality management systems – starting to use ISO 13485
- NHS technology adoption requirements
- Q&A
The course offers a framework, which when coupled with subsequent practical application experience enables attendees to develop the following professional practice skills:
- Start to critically evaluate the UK and international medical device regulatory frameworks and standards and justify a compliant regulatory strategy for a specific device.
- Apply and adapt ISO 14971 risk management principles to produce a comprehensive risk management file for a novel device concept.
- Design the core structure of a ISO 13485‑aligned quality management system appropriate to an SME, e.g. key procedures, records and supplier controls.
- Be able to produce an embryonic blueprint that aligns product development, clinical evaluation and NHS procurement pathways, resulting in the development of medical device history and NHS adoption files.
- Critically appraise clinical and economic evidence requirements for NHS adoption and construct an evidence generation plan that balances regulatory, clinical and commissioning needs.
- Lead and justify an ethical, regulatory and commercial decision for a device development pathway, demonstrating independent judgement, risk awareness and a plan for post‑market surveillance and lifecycle management.
The next course will run in November 2026.
