Learn by doing
We emphasise application over theory alone, using real-world examples.
Our courses are designed to show you how experts naivgate medical device regulations in the real world.
Quality Learning Materials
We have created and collated the highest-quality materials available online, to complete your learning portfolio.
Freely shared knowledge
Our tailor-made resources and tools were designed and used by regualtory affairs professionals. Now we have made them available to everyone.
You’re in good hands
We are the creators of several leading online Regulatory Affairs Courses
Interactive Courses. key Topics.
Our video courses are dynamic, engaging and interactive. We break down complex topics with practical examples and tips.
We cover the key topics to help you gain compliance in the EU and US. This represents over 70% of global medical device markets.
Primer: EU MDR
Introduction to the new European Medical Device Regulations 2017/745
Primer: US FDA
An overview of the US regulatory pathways, including new e-Star programs
Deep Dive: Clinical Evaluation Reports
In-depth guide to compiling an EU MDR-compliant CER and literature search
Deep Dive: Risk Management
Detailed risk management course with creation of a complete Risk Management File to meet ISO 14971, EU and US requirements.
Deep Dive: Post-Market Surveillance
Focused course to understand PMS requirements in the EU and US, including PMCF under the MDR
Deep Dive: Quality Management
Deep dive into the creation of a QMS compliant to EU and US requriements
Meet SAGE.
EU Submission Builder for Small Businesses
Designed by seasoned professionals for self-starters. SAGE guides you through every step to create an approval-ready EU MDR 2017/745 submission, entirely in house.
No subscriptions. No consultants needed.
Achieve Regulatory Independence with SAGE.
Our Services
Training Courses
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Learn about European and US regulations
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Primers for foundations and Deep Dives on specific topics
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Developed using feedback from Notified Bodies and US FDA
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Q&A sessions and community forum
Submission Builder
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SAGE AI is our dedicated submission building platform.
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Cloud-based tool to help you compile an EU MDR 2017-745 Submission
Free Resources
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Access tools created by regulatory professionals
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Reference guides and wizards available for free
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Whitepapers with latest regulatory updates