The release of the Medical Device Regulations (EU-MDR) has put significant pressure on medical device companies to closely scrutinize the new regulations, assess the impact on their own organization, and implement compliant processes and procedures accordingly.
As important deadlines approach for implementing the final version of the EU-MDR, medical device manufacturers should be focused on planning and implementing their transition program now.
We hosted a free webinar explaining an adaptable step-by-step process for effective EU-MDR transition.
In this webinar, we discuss a brief overview of the basics of the EU-MDR, focusing specifically on key changes before exploring how to plan and scope your EU-MDR transition program, conduct a thorough gap analysis specific to EU-MDR transition, scale your transition program, and implement changes successfully.
Presenter Larry Stevens, RAC, has held almost every field position within FDA during his 21-year career with the Agency. He has over 18 years of experience in the medical device industry, rising from an RA Manager to Vice President of RA/QA/Clinical for major class III device manufacturers. He specializes in planning, creating, and auditing quality systems as well as creating clinical plans, including protocol development, case report form development, and implementing and managing clinical trials. He also assists in design control to meet FDA requirements. Larry is a professional speaker who regularly trains on all aspects of FDA requirements while offering practical, successful solutions to FDA problems.