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The 2015 Medical Device Mini-Roadshow
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Designed to help medical device manufacturers, quality and regulatory professionals, and industry consultants understand and prepare for upcoming changes in EU regulatory requirements and CE Marking technical documentation /clinical evaluation expectations. BSI is an accredited third-party certification services provider and a leading EU Notified Body specializing in medical technology.

4/16/2015
When: Thursday, April 16, 2015
8 a.m. - 12:30 p.m.
Where: Chicago Marriott Naperville
1801 North Naper Boulevard
Naperville, Illinois  60563
United States
Contact: (888) 429-6178

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BSI is pleased to be supporting the medical device manufacturer regulatory affairs and quality assurance professionals by offering the opportunity to attend our second annual Mini-Roadshow program. 

Our exclusive half-day Roadshow program will provide the latest update on topical changes proposed on European medical device regulations, ISO 13485, MDSAP and Unannounced Visit experience. Key technical sessions will also review current expectations and best practices for CE Marking clinical data evaluation and common problems with technical documentation supporting compliance with EU medical devices directives. 

Also showcased during the morning will be an innovative new solution for managing and maintaining awareness of the latest draft/published standards to support medical device compliance and an effective tool for managing QMS actions. 

We invite you join the BSI experts to discuss critical topics and receive valuable timely insights from the perspective of the leading North American CE Marking medical device Notified Body, ISO 13485 registrar and the first national standards body.

Schedule:
  • 8:00 am – 8:30 am – Registration
  • 8:30 am – 12:30 pm – Meeting 

Topics:

  • European Regulatory Update - CE, 13485, OBL
  • Clinical Data Evaluations Lessons Learned
  • Tea Break
  • Two Tools - Compliance Navigator & Action Manager
  • Technical Files - Key Pitfalls
  • UAV & MDSAP Update

To register and for more information, click HERE.

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