Setting and Measuring Quality Objectives for Medical Devices - Webinar Recording/Transcript

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Setting and Measuring Quality Objectives for Medical Devices

Device quality must be implemented and communicated to the FDA, on pain of warning letters or worse. The rules and procedures are technical, involving both FDA rules and ISO 13485:2016. But mastery can be accomplished in only 90 minutes.

FDAnews has reached out to Dan O’Leary for guidance. Mr. O’Leary, one of our most popular presenters, will walk you through the process and give you compliance tools to make warning letters a thing of the past. You’ll discover: 

  • QSR requirements for the Quality Policy and Quality Objectives
  • Methods the FDA investigator uses to verify compliance
  • Additional requirements from ISO 13485:2016
  • Sample Quality Policies illustrating the requirements
  • Methods to develop Quality Objectives from the Quality Policy
  • How to describe of the three types of metrics
  • Use of Excel to develop a graphical approach to the metrics
  • And much more!

Special Bonus Material: Participants receive a checklist to help ensure the system is prepared for your next FDA Inspection, Notified Body audit, or MDSAP audit.

Warning letters aren’t the only reason to sign up. Quality improvements lead to smoother manufacturing, greater patient safety, less liability risk and greater profits in the long term — a payoff well worth 90 minutes of your time.

This presentation focuses on Quality Policy, Quality Objectives, and associated metrics, subjects of particular interest to:

  • QA/QR/QC
  • Production managers
  • QMS process managers
  • Continuous improvement specialists
  • Quality engineers
  • Management representatives
  • Management review attendees
  • Consultants

Dan O’Leary is President of Ombu Enterprises LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management.