Medical device manufacturing is among the most regulated sectors, demanding strict adherence to quality systems and product standards. These regulations aim to guarantee that manufacturers consistently develop, produce, and distribute medical devices that meet safety standards and fulfill their intended functions.

ISO 13485 provides a framework for implementing and maintaining a comprehensive quality management system tailored to the specific needs of the medical device industry.

During this webinar, CMTC experts Eliot Dratch and Lynn Zhao discuss:

  • The benefits of ISO 13485 certification
  • ISO 13485 certification requirements
  • Similarities and differences among ISO 13485, ISO 9001, FDA 21 CFR 820, MDSAP, & cGMP
  • Resources available to help manufacturers achieve ISO 13485 certification & other industry accreditations

This webinar was originally presented on March 6, 2024 at 11:00 AM PT. 

Meet the Speakers


Eliot Dratch Headshot - 200x200

Eliot Dratch
Quality Practice Lead

Lynn Zhao Headshot - 200x200

Lynn Zhao
Sr. Lean Six Sigma Consultant


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The material in this webinar is for informational purposes only. It should not be considered legal, financial, or other professional advice. CMTC advises you to consult an attorney or other appropriate professional to determine what may be best for your individual and unique needs. The presentation is not designed to be read by itself, nor to make a decision strictly on its content. It is intended for educational purposes only. Images used may have come from many sites found on the web, no copyright infringement is intended. All rights reserved for images by the original image owner. While CMTC takes reasonable steps to ensure that the information contained in this webinar is accurate, CMTC makes no guaranty in this regard. Further, CMTC has done its best to ensure that the information provided on our website, including a downloadable copy of this PowerPoint presentation, is accurate and provides valuable information.