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.
Clients we have served
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 EU Medical Device Regulations 2017/745
Primer: US FDA
Learn about US regulatory pathways, including e-Star
Deep Dive: Clinical Evaluation Reports
Compiling an EU MDR-compliant CER and literature searching
Deep Dive: Risk Management
Creation of the complete Risk Management File to meet ISO 14971, EU and US requirements
Deep Dive: Post-Market Surveillance
PMS requirements in the EU and US, including PMCF under MDR
Deep Dive: Quality Management
Creation of a QMS compliant to EU and US requirements
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
Resources and tools
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Premium tools created by regulatory professionals
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Free reference guides and wizards
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Whitepapers with latest regulatory updates