The clock is ticking!

The clock is ticking!

Streamline your transition to the European MDR and IVDR with BSI Compliance Navigator

Streamline your transition to the European MDR and IVDR with BSI Compliance Navigator

Red Overlay
Red Overlay

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.

Smart tools that save you time and money

Compliance Navigator holds over 4,000 documents essential for medical device and IVD compliance. With 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.

  • Device-specific profiles

You can create regulatory profiles for each device, 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.

  • Smart Support and expert commentary

You can prepare for the navigation to the MDR and IVDR with topic-by-topic Smart Support, with action points and practical guidance. You'll also interpret changes to new standards correctly, as our expert commentary provides context and guidance.

  • 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 for reducing risk, maintaining competitiveness and maximizing profitability.


What users love

See how these companies use Compliance Navigator to save time, avoid mistakes and stay a step ahead.

Case study 5 - ELLA-CS

Customer Testimonials

Case study 4 - Hologic

Case study 3 - Axonics

Case study 2 - Tissue Regenix

Case study 1 - Smart Surgical

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 4,000 BS, ASTM, AAMI, CLSI and other internationally recognized standards;  relevant EU and US regulations including the MDR and IVDR; FDA guidance; and expert commentaries.