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FDAnews Announces Medical Device Risk Management Conference, July 11-12, 2013, Boston, MA

m.  The new standards include:

  • IEC 60601-1, Medical electrical equipment — Part 1: General requirements for basic safety and essential performance
  • IEC 62304, Medical device software — Software life-cycle processes
  • FDA Draft Guidance — Applying Human Factors and Usability Engineering to Optimize Medical Device Design
  • The basic concepts of the assurance case

Seating is at a premium for this event — Register today.  Other areas the event will focus on include:

  • How the FDA and international regulatory bodies measure the severity of a risk and what the different levels of seriousness are
  • How to create and administer a risk management file — think of it as your risk management file cabinet
  • Understand how to score risks and create a risk "scorecard" — how to use severity and probability
  • Tips to assure that all your risk management reports contain the 9 checklist items all reports should have
  • And much more

You'll leave this workshop a much better risk management professional.

Register today

Who Will Benefit

  • Project managers involved in design and development
  • Design engineers
  • Quality engineers
  • Manufacturing engineers
  • Quality auditors
  • Production managers
  • Scientists involved in device research and development
  • Medical staff evaluating risk, safety or effectiveness
  • Quality or regulatory staff assigned to complaint, CAPA or MDR management
  • Training personnel
  • General/corporate counsel
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