New one-day programme equips MedTech professionals with the regulatory and development knowledge needed to comply with high-risk AI obligations before enforcement begins
London, UK. April 2nd 2026 — Educo Life Sciences, a specialist training provider for the pharmaceutical, biotechnology and medical device industries, has announced a new course designed to help MedTech companies prepare for the EU AI Act’s high-risk obligations, which take full effect in August 2026.
The course, Creating AI in Your Medical Devices: A Regulatory & Development Overview, runs as a live online session on 7 July 2026. It covers the regulatory and standards landscape across the EU, US and international frameworks, with a particular focus on what manufacturers of AI-enabled devices need to have in place before enforcement begins.
Why This Matters Now
AI is already embedded in diagnostic imaging, clinical decision support, digital pathology and predictive modelling tools across the medical device sector. Under the EU AI Act, AI systems used in healthcare are classified as high-risk, which means manufacturers face new obligations around data governance, bias control, technical documentation, human oversight and post-market performance monitoring.
These requirements don’t replace the Medical Device Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR). They sit alongside them as a complementary compliance layer. For companies already navigating MDR and IVDR conformity assessment, the AI Act adds specific expectations around how AI components are designed, documented, monitored and governed throughout their lifecycle.
With core obligations applying from August 2026, the window for preparation is closing.
“As AI becomes embedded within medical devices, the challenge isn’t the algorithm itself — it’s proving that it has been developed systematically, remains reliable over time, and continues to perform as intended in a real clinical environment. That’s where many organisations underestimate the level of rigour required.” – Richard Young
What the Course Covers
Led by Richard Young, a medical device industry specialist with over 25 years of experience across regulatory affairs, GMP, GLP and clinical affairs, the course addresses the practical questions that MedTech teams are grappling with right now: how the EU AI Act interacts with MDR and IVDR, what the FDA’s latest guidance means for AI-enabled features, and how emerging IEC and ISO standards apply to development and submission workflows.
Participants will come away with a clear understanding of Good Machine Learning Practice principles, lifecycle and evidence-generation strategies for AI-enabled devices, and the documentation and change management processes needed for compliant submissions.
The programme is designed for regulatory affairs and quality assurance professionals, R&D and software development teams, clinical and evidence generation specialists, and product and business strategy leads who need to understand the commercial implications of AI regulation.
Course Details
Course: Creating AI in Your Medical Devices: A Regulatory & Development Overview
Date: 7 July 2026
Format: 1-day live online (4 hours of learning)
Early bird price: £280 (20% discount when registering before 12 June 2026)
Standard price: £350
Addressing a Growing Skills Gap
The course launch comes at a time when external training demand across the life sciences sector is rising. Educo’s own 2026 Training Report, based on five years of post-course feedback data, found that 26% of professionals now say their organisation provides no internal training on the topics they need most. That’s the highest figure recorded since tracking began in 2021.
At the same time, 39% of respondents cited keeping up with regulatory changes as a primary motivation for attending training, up from 34% the previous year. With the EU AI Act introducing an entirely new compliance layer for AI-enabled devices, the demand for practical, expert-led guidance in this area is only going to grow.
Comment from Educo Life Sciences
Alexander Pearce, Director at Educo Life Sciences, said: “AI is already changing how medical devices are developed, tested and monitored. But the regulatory expectations are moving just as quickly. We designed this course to give MedTech professionals a clear, practical understanding of what compliance looks like under the EU AI Act, the FDA’s evolving guidance and the new standards being developed. August 2026 is not far away, and companies that start preparing now will be in a much stronger position.”
About Educo Life Sciences
Educo Life Sciences is a specialist learning and development provider delivering technical training to the pharmaceutical, biotechnology, cell and gene therapy and medical device industries. The company offers live online, on-demand and bespoke team training programmes designed to develop the skills and knowledge life science professionals need to perform with confidence, meet regulatory requirements and advance their careers. Clients range from university spin-outs to established pharmaceutical and biotech organisations across the UK, Europe and internationally.
Website: educolifesciences.com