Regulatory document management
Transforming how medical device and IVD manufacturers manage and access regulatory documents to save time, maximise resources and reduce risk.
Try Compliance Navigator for free, it couldn't be easier
Get unrestricted access to subscriber-only features, over 7500 documents and training for your team for 30 days.
Digital tools that save you time and money
BSIs Compliance Navigator is the smart, simple way to manage your regulatory information for Medical Device and In Vitro Diagnostic products with UK, EU and MDSAP requirements. With over 7,500 documents and multi-user access, it’s available to your whole team.
Alerts to changing standards
Put your team on the front foot, with alerts for when standards change and advance warnings for upcoming changes to BS standards.
Profiles and Templates
You can create regulatory profiles and templates, so you have the information you need in one place, along with links to relevant content outside of Compliance Navigator.
A comprehensive guide
You can see the full text of standards, legislation and guidance, so you don’t miss anything important.
Access the EU MDR and IVDR as well as MDSAP regulations
Smart Support and expert commentary
Fast track your understanding of the MDR, IVDR and MDSAP regulations with Smart Support and guidance.
- You'll also interpret standards correctly with our expert commentaries
Track changes
You’ll find it easy to see what’s new, with ‘red line’ changes between versions.
And you'll have a powerful tool that helps you avoid risk, stay competitive and maximize profitability.
Make the change
There’s no room for error in medical device and IVD standards. You need all your team working with the same information, wherever they are. You need them to know when it’s going to change, to know the instant it changes and to know what those changes mean for your devices.
Proceed with confidence
Use the most authoritative source of medical device standards information on the market. With over a century of experience, BSI is trusted by thousands of companies worldwide to help them stay compliant and grow their businesses.
“BSI is very professional… and consistent with the services provided.” Regulatory Affairs Manager, USA
Compliance Navigator holds over 4,500 documents essential for medical device and IVD compliance, including internationally recoginized standards, European and MDSAP regulations and guidance.
What users love
A selection of testimonials from our clients.
“It’s not just the direct time saving of locating information quickly, it’s a much faster, accelerated workflow.”
“Easy to set up, understand and use. Being notified of upcoming changes is particularly useful…I can go quickly into the system and see how it will impact the product and our timelines.”
Next steps
Take a tour to see how Compliance Navigator can help your business or contact us for a quotation.
