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Creating AI in Your Medical Devices: A Regulatory & Development Overview
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Creating AI in Your Medical Devices: A Regulatory & Development Overview

3 February 2026 | Short Online Course

Original price was: €415.Current price is: €332.

1-Day Live Online training | Learn how to design, develop, and submit AI-enabled medical devices under evolving EU, US, and international frameworks.

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Enrol before 16 Jan to save 20% (Feb Course)

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Learn more about the course by toggling through the tabs below. Scroll down to view the agenda, trainer info and who should attend.

Course Overview

 

Artificial Intelligence (AI) and Machine Learning (ML) are reshaping the medical device industry, driving innovation in diagnostics, digital therapeutics, and decision-support systems. However, their complexity introduces unique regulatory and design challenges. Regulators in the EU, US, and globally are updating frameworks to ensure the safety, performance, and trustworthiness of AI-enabled technologies.

 

This course provides a clear overview of the regulatory and standards landscape, practical design considerations, and upcoming developments such as the EU AI Act, FDA guidance on AI features, and new IEC standards. Participants will gain the knowledge to anticipate regulatory changes and prepare compliant submissions for AI-based devices.

 

Learn more about how we deliver live online training.

Download the Agenda

 

You can view the agenda by scrolling down on this page. If you would like to receive a PDF version with all the course information, please complete the form below.

 

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Key Learning Objectives

 

  • Understand the principles of AI/ML design for regulatory compliance (Good Machine Learning Practice)
  • Review the latest EU and US regulatory changes for AI in medical devices
  • Interpret the implications of the EU AI Act and its relationship with MDR/IVDR
  • Navigate the FDA’s guidance on AI/ML-enabled features and change management
  • Recognise the role of developing IEC and ISO standards for AI in medtech
  • Apply lifecycle and evidence-generation strategies to AI-enabled devices

What is Included in a Short Live Online Course?

 

  • Direct access to an expert trainer through interactive and engaging sessions
  • Unlimited access to session recordings for 2 weeks after the course (live format)
  • One month of unlimited access to recordings and slides (on-demand format only)
  • Validated certificate of attendance, available to download or share on LinkedIn

Course Dates

 

Find out when this course is running so you can plan your training. Scroll down to view the full agenda.

3 February 2026

1-Day Live Online Training
Register at the top of the page.

7 July 2026

1-Day Live Online Training
Register at the top of the page.

Group Discount

 

If you want to train a small group, we offer a group discount between 5% and 50% depending on the course and number of attendees.

 

For a quote, complete our contact form by following the link. Get in touch.

Customised Team Training

 

We also design and deliver fully customised team training focused on your products, processes, technologies and challenges. This is ideal for specific training requirements or larger groups. Please get in touch with us for more information.

 

For more information, complete our contact form by following the link. Get in touch.

Full Course Information and Pricing

 

  • To attend the full course, you must register online at the top of the page by selecting the course dates from the drop-down and clicking enrol to add the course to your basket. Once added, please follow the checkout instructions to pay via credit card or bank transfer.
  • There are price tiers for this course. The dates of these are located above. The earlier you register the more you save.
  • The full training course is delivered online.
  • For live online courses – The dates and times of modules/sessions are subject to change.
  • For live online courses – The module/session durations are approximate.

 

Frequently Asked Questions (FAQs)

Learn more about the course by toggling through the tabs below (Agenda, Trainer and Who Should Attend?)

 

Course Outline

Course Information

  • The course begins at the time stated at the top of the page
  • The course is broken up into modules outlined below
  • There will be breaks between modules

3 February 2026 | 7 July 2026

1-Day Live Online Training
Register at the top of the page.

Session 1

120 mins | 10:00 AM UK

Introduction to AI in Medical Devices

  • Definitions and scope: AI, ML, Deep Learning in medical devices
  • Real-world examples: diagnostics, decision support, monitoring systems
  • Regulatory perspectives: how AI differs from traditional SaMD

 

Designing AI for Compliance

  • Good Machine Learning Practice (GMLP) – principles for trustworthy design
  • Data considerations: training sets, bias, transparency, traceability
  • Explainability and human oversight in AI-enabled systems

 

Regulatory Frameworks & Classifications

  • MDR/IVDR rules and their impact on AI-based devices
  • FDA categorisation of AI/ML-enabled devices
  • Global perspectives: IMDRF guidance, MHRA position papers
Session 2

120 mins | 10:00 AM UK

Evolving Regulatory Changes & Developments

  • EU AI Act: scope, risk classification, and interaction with MDR/IVDR
  • FDA guidance on AI/ML features – Action Plan and Predetermined Change Control Plans (PCCPs)
  • Emerging global trends in AI governance

 

Standards & Best Practices

  • Overview of relevant IEC/ISO standards in development (e.g., IEC 62304 updates, IEC TR 60601-1 guidance for AI, ISO/IEC JTC1 work on AI)
  • Role of standards in demonstrating safety, performance, and compliance

 

Lifecycle, Submissions & Post-Market Considerations

  • Strategies for clinical/performance evaluation of AI-enabled devices
  • Managing updates in continuously learning systems
  • Post-market surveillance, monitoring, and regulator expectations

 

Wrap-Up and Case Studies

  • Examples of AI-based devices successfully regulated in EU and US
  • Lessons learned and regulatory outlook
  • Interactive Q&A

Richard Young has over 20 years’ experience in the medical device and IVD industry with products such as class 3 implants to electromedical infusion systems. Richard has extensive experience in regulatory affairs, GMP (quality), GLP (laboratory testing) and clinical affairs. Richard has held various positions within industry such as QA/RA Manager and Director, Quality Assurance and Regulatory Compliance at various companies including Biomet, Plasma Surgical and Zimmer Limited.

 

Richard has been an independent consultant for over 6 years, supporting companies with regulatory and quality advice on a range of different products. He has extensive experience of European regulations including the MDD, IVDD and more recently the MDR and IVDR. In addition, Richard understands the US FDA requirements for devices and diagnostics. He also has a comprehensive working knowledge of device ISO standards such as 13485 and 14971.

 

Richard has worked on many software related projects for clients helping them achieve regulatory compliance in the EU. In addition, he has delivered both online and classroom training courses on medical device software. He can provide multiple examples and case studies during training, drawing on his extensive industry experience.

 

This course is for professionals involved in:

  • Regulatory Affairs & Quality Assurance – preparing AI submissions and ensuring compliance.
  • R&D and Software Development – designing AI features with regulatory requirements in mind.
  • Clinical & Evidence Generation – supporting validation of AI models.
  • Product & Business Teams – understanding strategic impacts of AI regulations.

On-Demand Access

Can’t wait for the next course date?

Get instant access to the training materials by selecting ‘On-Demand’ from the drop-down menu above. Start learning at your convenience. You’ll also be added to the next live session, giving you the opportunity to attend and interact directly with the trainer if you wish.

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Creating AI in Your Medical Devices: A Regulatory & Development Overview

3 February 2026 | Short Online Course

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