The first major revision to device regulations since 2007 has been released and the changes are significant. Although the MDR won't take effect until early 2020, smart companies are planning ahead to beat the crush of companies that will inevitably wait until the last minute, overwhelming EU Notified Bodies. Ronald Boumans, Senior Global Regulatory Consultant for EMERGO (and former IGZ compliance inspector in The Netherlands) outlines the most important changes you need to know in this 35 minute recorded webinar from September 2016. Topics addressed include:
- How the MDR is organized
- Scope of the legislation
- Device classification rules
- New clinical evaluation requirements
- UDI and EUDAMED database
- Adverse event reporting
- And much more...
Free white paper: Understanding Europe's New Medical Devices Regulation
Europe's well-established medical device regulations are about to change. And you probably have a lot of questions. What do these changes mean and how will they affect your company?
Free white paper: How ISO 13485:2016 Impacts Medical Device Companies
The new ISO 13485 revision is finally here and, for medical device manufacturers, this is big news. You probably have plenty of questions about how the new standard will affect yoru company: do I have to completely overhaul my QMS? When do I have to comply?