Falls Church, VA (PRWEB)
June 23, 2017
Understanding and Implementing EU Medical Device Regulation
**Presented by FDAnews and Ombu Enterprises**
July 11-12, 2017, Cambridge, MA
NOTE: There are a limited number of seats available for the workshop.
The EU has up-ended its device rules.
The Medical Device Regulation (MDR), which replaces the existing Medical Device Directive (MDD), is packed with new provisions, changes to existing ones, inclusions and exclusions. These changes include:
- Manufacturers’ entire product portfolios will need to be re-approved
- But the rules for accrediting Notified Bodies (NB) aren’t even final yet
- Standards just released, such as the ISO 13485:2016, will change again to align with the new MDR
- Turnaround time for incident reporting will drop from 30 to only 15 days
And this barely scratches the surface.
Here’s how to cope.
Come to Boston July 11-12 for two intense days of:
- Learning all that’s new and changed
- Understanding how to comply
- And, perhaps best of all, hands-on application with a product
In a special workshop feature, attendees will apply the MDR’s new provisions to one of their own products that currently has the CE Mark under the MDD (especially Annex II) and satisfies the U.S. UDI rule.
Workshop leader, Dan O’Leary of Ombu Enterprises LLC, is a favorite of thousands of conference attendees for his ability to simplify the most complex device-related topics.
Meet the Presenter:
Dan O’Leary, President, Ombu Enterprises, LLC
Dan has more than 30 years’ experience in quality, operations and program management in regulated industries including, aviation, defense, medical devices and clinical labs. Dan is now President of Ombu…