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Build your Foundation
Entry level courses to master key regulatory topics.
Accessible, comprehensive, and designed for learners
of all levels and experience.
Why Primers?
Knowing where to begin tackling regulatory compliance can be daunting. Our Primers are designed to condense key regulatory topics into practical and informative 90-minute courses.
These courses are written and presented by experts in global medical device regulations. We understand the most common pain points, knowledge gaps and challenges you face, and have written these courses with those in mind.
Join an active community of learners in an open forum, with access to regulatory professionals for all your specific questions and concerns.
Our Primers
European Medical Device Regulations
The new EU Medical Device Regulation (2017/745) represented the largest update to device regulations in Europe in over 20 years.
Four years on, the MDR continues to evolve and shift, with ever-changing requirements for medical device manufacturers looking to enter the European Single Market.
This Primer, originally released in 2020 and now refreshed in 2024, guides you from the basics of European medical device regulation, all the way through to the latest updates and developments from the MDR saga.
1,600+ learners enrolled.
US FDA Medical Device Regulations
The USA represents a world-leading medical device market with a unique regulatory framework. Navigating the US regulatory landscape is key to launching any global medical device.
In recent years, the FDA has embraced innovation and change at a rapid rate. Systems and processes have been overhauled, so device manufacturers also need to adapt.
Originally launched in 2021, this best-selling course has been revised in 2024 to cover the latest FDA topics, including the much-anticipated launch of the e-Star program, using real-world examples and exercises.
2,600+ learners enrolled.
Ready for the next step?
View our Deep Dives for more in-depth learning of key topics