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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: US$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
Speaker Profile
Jeff Kasoff, RAC, CMQ/OE has more than 30 years in Quality and Regulatory management. Over that time, Jeff has implemented and overseen quality system operations and assured compliance, at all sizes of company, from startup to more than $100 million in revenue. This multi-faceted experience makes Jeff uniquely qualified to address compliance issues across the entire range of company sizes. Jeff has also been primary liaison with FDA inspectors and notified body auditors, giving him first-hand experience with the most common issues surfaced by regulatory agencies. Jeff received his Regulatory Affairs Certification from RAPS , his Manager of Quality and Organizational Excellence certification from ASQ, and his Lean Black Belt from IIE.


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