Medical Device and IVD Regulatory Affairs
Practical, Independent Support.
Practical RA provides regulatory affairs services for medical devices and in vitro diagnostic medical devices (IVDs), supporting manufacturers with compliant market access and ongoing regulatory obligations across the EU, US, Australia and key international markets.
We are dedicated to empowering small businesses with practical knowledge to navigate global regulatory requirements.
Regulatory Support for Medical Devices and IVDs
EU MDR / IVDR Support
Practical assistance for EU regulatory compliance and transition activities.
US FDA Support
Hands-on services to deliver 510(k) clearance, plan pre-submissions or identify suitable Product Codes and predicates
Regulatory Strategy
Support across classification, technical documentation, and regulatory pathways in global markets.
Australian Sponsor (TGA)
Australian Sponsor services for overseas manufacturers supplying medical devices and IVDs in Australia.
Our client focus
We work with organisations that value clear regulatory advice, defined responsibilities, and practical solutions. Our approach is structured, risk-based, and aligned to regulatory expectations.
- Overseas medical device and IVD manufacturers
- Start-ups and established manufacturers
- Organisations entering new markets or managing regulatory change
Why Practical RA?
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.
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.
Regulatory Resources
EU MDR Transition Guide
Key considerations for transitioning to EU MDR compliance.
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FDA eSTAR
Learn how to navigate and master the FDA eSTAR and pre-STAR regulatory submission
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Australian Device Regulations
An introduction to TGA regulatory requirements for medical devices.
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European Office: Practical RA
67 Rue Saint-Jacques, 75005 Paris, France
Australian Office: Practical RA Pty Ltd
410 Concord Road, Rhodes NSW 2138, Australia