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

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
  • Refund Policy

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
Jeff Kasoff, RAC, CQM, is the Director of Quality at Medivators, a leading manufacturer of consumables and instrumentation in the endoscopy field. Among his responsibilities is multi-facility oversight of the CAPA system. In his 20+ years of Quality and Regulatory management, Jeff has implemented and overseen document control systems at all sizes of company, from startup to $100 million in revenue. Over that time, he has also been primary liaison with FDA inspectors and notified body auditors. Jeff received his regulatory affairs certification in 1996, and his certified quality management certification in 2013.


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