ISO 13485: What’s New and How It Affects You - Webinar CD/Transcript

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ISO 13485: What’s New and How It Affects You

Do you know the ins and outs of the new, revised ISO 13485 standard?

After many years of the same old, same old, manufacturers will need to make adjustments.

Kim Trautman — Executive Vice President, NSF Health Sciences, Medical Device International Services — and former Associate Director, International Affairs Office of CDRH, will explain the new ISO 13485 requirments.

After this session you will be able to:

  • Determine the consistencies — and inconsistencies — with other documents in the ISO family.
  • Implement a supply chain system compliant with the revised standards.
  • Understand how the revised standard and guidance really fits in with the ISO/TR t14969 technical report

If you are even a little bit unsure of how these revisions will impact your company, you must order this webinar CD and transcript.

  • Quality Managers
  • Quality Engineers
  • Quality Auditors
  • Regulatory Managers
  • Design & Development Managers
  • Design Engineers
  • Production Managers
  • Production Supervisors
  • Manufacturing engineers
  • Members of your transition team

Kimberly Trautman, Executive Vice President, NSF Health Sciences, Medical Device International Services
Kim Trautman has more than 30 years of experience in medical device quality systems and international regulatory affairs. She is focused on expanding international regulatory affairs and compliance services for NSF’s medical device clients, including expanding medical device training services worldwide and spearheading the development of an independent, third-party regulatory certification program. Ms. Trautman previously worked for the FDA’s CDRH where she led the CDRH’s international efforts and initiatives. She was responsible for writing the current U.S. FDA Medical Device Quality System regulation and preamble published in 1996. She also developed and implemented the extensive quality system regulation roll out and training programs, and led continuing harmonization efforts with ISO 13485.