Key differences in Design Control Requirements between ISO13485:2003 and the FDA Quality System Regulation

Instructor: Dennis Moore
Product ID: 700192
  • Duration: 60 Min

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Detailed analyses of the sections of the QSR design control regulations that have requirements not present in the ISO 13485:2003 standard.


Many companies are confidant that their ISO 13485:2003 design control system is compliant to the Quality System Regulation, yet FDA conducts an inspection and FDA 483 design control cites are written and warning Letters, seizures or worse ensue.

This presentaion will review the sections of the QS control regulation which have requirements not present in the ISO 13485:2003 standard. Actual design control/FDA data will be discussed, which shows the agencies’ design control compliance directions. FDA investigator techniques will also be discussed.

Areas Covered in the Seminar:

  • What are the key differences between design control rules of the QS Reg. and the ISO 13485:2003 standard
  • QSIT design control audit process
  • How do I counteract a possible FDA 483 cite
  • Where does risk management fit in
  • How do I correct the FDA compliance gaps in my design control process
  • Should I create one quality system which complies to both rules
  • How do I better audit my design control system
  • How do I train my staff in design control compliance

What Attendees will Learn:

  • How do I answer an FDA 483 cite to FDA
  • How do I improve my design control Internal audit process
  • What type of resource commitment is there achieve dual compliance

Who Will Benefit:

This web seminar will provide your firm with key insights on how to identify compliance gaps in ISO 13485:2003 design control quality systems. The webinar will help you avoid FDA 483’s and warning letters The employees who will benefit include:

  • Regulatory Managers
  • QA Managers and employees
  • Government Auditors
  • Quality System Auditors
  • Industry Consultants
  • ISO 13485:2003 auditors

Instructor Profile:

Dennis M. Moore, is the President CEO and Founder of AUK Technical Services LTD (ATS). a worldwide consulting firm which specializes in Quality Systems and submissions for medical device and pharmaceutical companies. Mr. Moore is a former 22 year FDA credentialed Government investigator, Retired Peace Officer and author of many articles on quality system concepts. Mr. Moore has performed hundreds of FDA device and drug inspections, and written many FDA 483 and warning letter citations. He also has industry experience on the manufacturer side of the auditing desk.

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