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FDANews - Seventh Annual Medical Device Quality Congress

June 2 - 4, 2010 • Bethesda, MD

The theme for this conference is "From Risk Management to Postmarket Surveillance".

Their exclusive FDAnews survey of device-makers pinpointed your “Top 5” most important quality issues — risk management, design control, supplier quality, QSR compliance and postmarket surveillance — and this conference’s program is built around them. Attend and you will get answers to your toughest questions like these, and many more:

  • How will the CDRH pressure your firm to improve QA and engineering principles?
  • What about “sister suppliers” and regulations surrounding supplier management?
  • What new problems are field investigators uncovering?
  • How will the Unique Device Identifier (UDI) system and the Sentinel Initiative affect postmarket surveillance in your company?
  • And ... what’s up the CDRH’s sleeve for 2010 — and beyond?

Steve Niedelman will speak on the topic, "Managing Operations Effectively: Deliver Quality Devices and Always Be Audit Ready". He will also be part of the closing panel "Lessons Learned & Wrap Up" at the end of this conference.

Official Event Site

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