FDA Utilization of Patient Preference Information in Regulatory Development & Decision Making Patient advocacy and engagement have evolved into critical aspects of healthcare development and management in recent years, as patient and care partners seek greater...
1 Hour Video | John Howlett and Flemming Nielsen, LRQA
1 Hour Video | Roberto F. Refeca and Nathalia Iensen, Halyard Health, Inc
FDA MDR Enforcement Actions: Best Practices for Strengthening MedWatch Form Writing and Reporting A common enforcement action sited in FDA warning letters in recent years pertains to the failure to properly and fully complete a MedWatch Form (FDA 3500A). Complaint...
Key Postmarket Surveillance Considerations for Transitioning to the New EU Medical Device Regulation In light of recent approval of the EU Medical Device Regulation (MDR), manufacturers already in the European market must begin transitioning to meet the new...
1 Hour Video | Pamela F. Forrest and Scott D. Danzis, Covington & Burling LLP
1 Hour and 30 Minute Video | Erik Vollebregt, Axon Lawyers
1 Hour Video | Lynette Zentgraft and Elaine Tseng, King & Spalding
1 Hour Video | Julie K. Tibbets, Alston & Bird LLP
1 Hour Video | Val Surgenor, MacRoberts LLP