There’s no room for error in Medical Device 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.

• MDR/IVDR Smart Support

Understand how the new regulations apply to your business and how to plan for the transition.

• Alerts to changes

You’ll be alerted to upcoming standard changes, so you can plan accordingly.

• Device-specific profiles

You can create regulatory profiles for each device, so you have the information you need in one place – right down to what’s relevant to each aspect of development.

• A comprehensive source

You can see the full text of the new Medical Device and IVD Regulations, standards, legislation and guidance, so you don’t miss anything important.

• Expert commentary

You'll interpret changes to standards correctly, as our experts provide 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 that helps you avoid risk, stay competitive and maximise profitability.

Case study 1 - Smart Surgical

Case study 2 - Tissue Regenix

Case study 3 - Axonics

Case study 4 - Hologic

Customer Testimonials

• A service from BSI – over a century of experience

• The most authoritative source of Medical Device standards information on the market

• Trusted by thousands of companies worldwide to help them stay compliant and grow their businesses

Compliance Navigator holds over 3,000 BS, ISO, EN and IEC standards, EU Medical Device and IVD Regulations, FDA Regulations, EU Guidance, topic by topic MDR/IVDR Smart Support, and reference to all AAMI and relevant ASTM standards.