ISO 13485:2016 – Understanding The Changes And Requirements

The United States Food and Drug Administration (FDA) FDA has been utilizing information based on inspections conducted by third parties and other regulators in different circumstances pursuant to MDUFMA 2002.

Beginning in January, 2014, the FDA has been participating in a pilot program entitled “Medical Device Single Audit Program (MDSAP)” with other international partners. The MDSAP is intended to allow MDSAP recognized organizations to conduct a single audit of a medical device firm that will satisfy the relevant requirements of the medical device regulatory authorities participating in the pilot program.

For global medical device firms to be ready for auditing for quality management systems in accordance with the ISO 13485, it is imperative that firms become familiar with the recent changes made to the ISO 13485.

This webinar is intended to help you get familiar with the changes in the recent 2016 March version of ISO 13485 including differences with ISO 13485:2003.

This webinar will help you better understand, increase your awareness and familiarity with the recent ISO 13485:2016.

This webinar will provide great opportunities to develop your insight on what is best for your business under limited resources and circumstances when considering implementing ISO 13485:2016 for regulatory and certification purposes.

Areas Covered in the Session :
Applicable Laws
FDA Guidance
Major Misconception
ISO 13485 (March, 2016 version)
Differences between ISO 13485:2003 and ISO 13485:2016
Common Non-conformances During Regulatory Audits
Global Aspects of ISO 13485 Quality Management System (QMS)
ISO 13485:2016 Transition for Regulatory and Certification
Speaker’s PASS-IT Recommendations: Best Practices

Who Will Benefit:
Compliance Officers
Regulatory Affairs
Clinical Affairs
Quality Assurance
Research & Development
Anyone Interested in the ISO 13485:2016

Dr. David Lim

Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor ( As a leading industry speaker, Dr. Lim frequently presents global regulatory and quality compliance topics in various forums and meetings. Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past eight years. Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009.

Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker. Dr. Lim leads and directs all research projects including pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor. Dr. Lim currently serves as a member of the Advisory Board for Inspection Insider published by FDA News.

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance