An evolving regulatory landscape
There has been significant evolution in the European regulatory landscape over the past 10–15 years, particularly with respect to requirements for clinical evaluation.
This white paper will focus on the purpose of the clinical evaluation, some of the embedded requirements that may not be immediately obvious to all manufacturers, and in particular the importance of clinical evaluation planning and scope.
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
- Developing and maintaining a quality management system for IVDs
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.
