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Nice response to my questions and good suggestions for moving forward.

Some of these sessions are too basic - this one had a good mix of basic and details. The tips are helpful. One comment: a little more discussion regarding the use of Detection in FMEAs would be useful since many do not advocate its use. Thanks,

I especially liked that the Q&A session after the webinar was long enough to not only address my own questions but also to learn from the questions from the other participants in the webinar.

Very thorough understanding of the history/progression of the guidances, and very helpful evaluation of current and potential directions. Excellent presentation skills, very engaging.



ISO 13485: 2003 - A Straightforward Interpretation with Recommendations for Easy Implementation

Global CompliancePanel
Global CompliancePanel
Training Options
 Duration: 60 Minutes  
Recorded Access recorded version only for one participant; unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
Price: $295.00
Global CompliancePanel
Global CompliancePanel
Customer Testimonials
Instructor Jeff Kasoff
Product Id 600128

Overview: Development, implementation, and maintenance of an ISO 13485-compliant quality management system requires many resources and personnel to meet with success.

ISO 13485 is a wordy standard, drafted by individuals for many of whom English is not their primary language. This webinar is a section-by-section review of ISO 13485 in a clear concise manner, and provides suggestions for development of a compliant system.

Areas Covered in the Session:

  • The purpose of the standard
  • The structure of the standard
  • The requirements of the standard
  • Straightforward recommended implementation approach

Who Will Benefit:This webinar will provide valuable assistance to all device manufacturers who wish to have a better understanding of the requirements of ISO 13485. The employees who will benefit include:

  • Top management
  • Regulatory Management
  • Quality Management
  • Documentation Managers
  • Quality Engineers
  • Other personnel involved in development and implementation of the QMS



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