Regulatory Affairs for Digital Health & AI Medical Devices

This course contains the use of artificial intelligence

Digital Health products can scale quickly—but when your solution becomes Software as a Medical Device (SaMD) or includes AI/ML medical device functions, regulatory expectations change dramatically. This course is a practical guide to navigating EU MDR/IVDR and the US FDA approach to software, CDS, and AI, with a strong focus on what teams need to deliver in real life: a clear regulatory strategy, defensible evidence, and documentation that withstands review.

You’ll learn how to define intended purpose, intended use, and claims—your true regulatory starting point—and how to determine whether your product is a medical device in both the EU and the US. We’ll cover how to classify medical device software under EU rules (including common Rule 11 pitfalls) and what it means operationally when a Notified Body is involved.

From there, we move into execution: how to build a defensible technical file for medical device software, how to create a GSPR mapping that links every Annex I requirement to concrete evidence, and how to run a regulated software lifecycle with change control, versioning, release management, complaints, CAPA, vigilance, and post-market metrics. You’ll also learn cybersecurity-by-design as a patient-safety discipline—threat modeling, security testing expectations, vulnerability handling, and how to document it properly.

If you want to position your digital product for smoother audits, faster reviews, and fewer regulatory surprises, this course gives you the frameworks, checklists, and real-world examples to get there.