Getting to Yes from Regulators to Payers and Beyond - the Decision-Maker Gauntlet
Regulatory, Quality and Good Manufacturing Practices
The complexity of the global medical device regulatory landscape continues to increase. This session will discuss recent information shared at the September International Medical Devices Regulatory Forum (IMDRF) meeting and will include panelist reflections on these timely updates. Focus will include IMDRF activities and a deep dive look at initiatives designed as building blocks for the development of a Medical Device Single Review Program (MDSRP) to ultimately enable a single regulatory pre-market review to satisfy multiple regulatory jurisdictions.