Hear from industry experts today

With the MDR and IVDR, European regulators aim to ensure companies have a regulatory expert – a Person Responsible for Regulatory Compliance (PRRC) – at their disposal, to ensure that the company is meeting certain specific EU requirements. Complete the form for an overview of the requirements of MDR/IVDR Article 15.

Take advantage of our free medical device whitepapers 

Our whitepapers will help you understand how to perform better, reduce risk and make excellence a habit in your organization. See below some examples of other available whitepapers.

Interpret and implement standards and regulation with ease

BSI Compliance Navigator is the only platform designed by regulatory experts to help manage your medical device compliance, all in one place. Access thousands of standards and regulations, from MDR and IVDR to MDSAP requirements, we have you covered. 

What's more, Compliance Navigator will alert you of any upcoming changes to relevant standards and regulations, meaning you can prepare, far in advance. Use our Tracked Changes to see what's changed quickly and efficiently, followed by our Expert Commentary to help interpret and implement with ease. Save time, reduce risk and unlock market access with Compliance Navigator.

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