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Understanding and Implementing the ISO 13485 Standard

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$1,095.00 - 2 Days - 1.4 CEUs


Register now!

To sign up, click on prefered date below or call 800-374-3818.  For venue details, hover your mouse over the city.
 
06 Aug 09     
11 Aug 09     
15 Dec 09     
06 Oct 09     
31 Aug 09     
10 Sep 09
03 Nov 09     

 Course Objectives

SAI Global's 2-day course is the ideal learning opportunity toward understanding and successfully implementing ISO 13485:2003. The training provides the information and guidance needed to implement and/or understand ISO 13485 requirements. This intense analysis will guide companies toward reviewing current processes and systems, planning for change, and understanding the challenges and benefits of meeting/certifying to ISO 13485.

 Key Session Topics

  • Review of the ISO 13485 requirements

  • Direct comparison of ISO 13485 to the FDA GMPs/QSR and ISO 9001 standard

  • How to effectively implement ISO 13485

  • Regulators' approach to the ISO 13485 requirements

  • Risk management (ISO 14971:2007) requirements related to ISO 13485

  • How to proceed as a company by understanding your processes

  • Global Regulation Overview: ISO 13485:2003, Japan Ordinance 169, CMDCAS, and EU MDD

  • Product Liability concerns/benefits

 Who Should Attend?

  • General managers

  • Business unit managers

  • Quality and regulatory professionals

  • Management representatives

  • Internal and external auditors

  • Those who wish to get an understanding of the requirements and how to make them add value to your company

  • Consultants needing in-depth understanding of the requirements

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