FDAnews Announces: Understanding and Implementing EU Medical Device Regulation Workshop, July 11-12, 2017

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The EU has up-ended its rules and replaced the current three directives with two new regulations that are much tougher and promise to transform the way manufacturers do business abroad. FDAnews has teamed up with Ombu Enterprises Inc. to present a two-day workshop that brings manufacturers current with all the new rules and readies them to comply before the MDR and IVDR take effect.

Understanding and Implementing EU Medical Device Regulation
**Presented by FDAnews and Ombu Enterprises**
July 11-12, 2017, Cambridge, MA
http://www.fdanews.com/eumdreg

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 Enterprises, LLC, a consultancy focused on operational excellence and regulatory compliance serving small manufacturing companies. He has a Masters Degree in Mathematics; is an ASQ Certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer and Six Sigma Black Belt; and is certified by APICS in Resource Management.

Who Should Attend:

  •     Quality Managers/Engineers
  •     Risk Managers
  •     Regulatory Affairs
  •     Design Engineers
  •     Supply Chain Managers
  •     Production Managers/Engineers
  •     Document Control Specialists
  •     Marketing Managers
  •     Clinical Managers
  •     Clinical Evaluation Specialists
  •     Export Compliance Managers

Conference Details:
Understanding and Implementing EU Medical Device Regulation
**Presented by FDAnews and Ombu Enterprises**
July 11-12, 2017, Cambridge, MA
http://www.fdanews.com/eumdreg

Tuition:
Early Bird Registration: $1,597 (until June 13, 2017)
Regular Registration: $1,797

Easy Ways to Register:
Online:     http://www.fdanews.com/eumdreg
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
FDANEWS
+1 (703) 538-7665
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