Everywhere, regulators are tightening requirements – and the focus is on quality of clinical evidence.
– The European MDR effectively mandates clinical trials for high risk devices. Similar guidance has been issued in Australia.
– The US FDA requires more and more 510ks to include clinical data.
– In China the requirements for Clinical Evidence mandate clinical trials for most high risk devices, although recent announcements suggest China is becoming more flexible in its approach to international data.
We take a look at the emerging global trends and how to develop an international approach to clinical validation and Clinical Evidence Reporting.Download Slides Download 2 Download 3 Contact Us