Navigating the innovations and EU regulations
The medical device and pharmaceutical industries each share in a mission to improve health outcomes, from prevention to intervention. As a result of this shared mission, integration and overlap between these two industries has been taking place for decades. Over the course of this white paper, the different categories of combination products within the EU will be described along with the regulatory pathways designed to ensure they are safe and perform as intended.
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.
- The Differences and Similarities between ISO 9001:2015 and ISO 13485:2016
- Requirements for vigilance reporting and post-market surveillance?
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.