Our Regulatory Courses

We’ve crafted best-selling courses to meet every level of regulatory knowledge.

Our Primers are designed for new learners, while our Deep Dives allow more
advanced professionals to expand their knowledge and skillsets.

Primers ➤
Deep Dives ➤

Navigating medical device regulations is complex — whether you’re preparing an EU MDR submission, navigating the US FDA 510(k) pathway, or building your organisation’s first Quality Management System. Our online regulatory courses are designed by practicing regulatory professionals who work in industry every day, so you get practical, immediately applicable knowledge rather than textbook theory.

Each course is structured around the real-world questions and challenges that manufacturers, engineers, and regulatory teams face. We don’t just explain what the regulations say — we show you how to apply them to your specific device and situation.

EU Medical Device Regulations (MDR 2017/745)

US FDA Medical Device Regulations

Primers for New Learners

Deep Dives for Advanced Learning

Frequently Asked Questions

Our courses are designed for regulatory affairs professionals at all levels, from engineers and product managers stepping into RA roles for the first time, to experienced professionals who need to upskill on specific frameworks like EU MDR 2017/745 or US FDA 21 CFR. Startup founders and small medical device companies will also find our Primer courses particularly useful as an efficient introduction to regulatory requirements in key markets.

Our Primer courses require no prior regulatory knowledge — they start from first principles and build up systematically. Our Deep Dive courses assume a working familiarity with medical device regulations and are suited to professionals looking to develop specialist expertise in areas like Clinical Evaluation Reports, Risk Management, or Post-Market Surveillance.

All courses are delivered entirely online and are self-paced, meaning you can start, pause, and continue at any time. Lessons are short and focused, making it easy to fit learning around a busy schedule. You’ll have access to official guidance documents, templates, and additional resources alongside each lesson.

Yes — we offer dedicated regulatory courses for both the EU MDR 2017/745 and the US FDA regulatory framework. Our Deep Dive courses, such as Risk Management and ISO 14971 and Post-Market Surveillance, cover principles applicable across both major markets as well as other global jurisdictions.

Yes, a certificate of completion is issued for each course upon finishing all lessons. This can be used as evidence of continuing professional development (CPD) in regulatory affairs.