Medical Device Calibration Program - Webinar Recording/Transcript

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Medical Device Calibration Program: A Step-by-Step Guide

Devicemakers: The quality of your manufacturing is only as good as the quality of your measuring equipment. But you can spend a fortune on metering devices and still turn out shoddy products. It all depends on how well they’re calibrated.

Listen in for a roll-up-your-sleeves learning session led by the guru of quality in device manufacturing, Dan O’Leary of Ombu Enterprises. You’ll pay close attention as he walks you through the intricacies of FDA’s requirements: 

  • The role of monitoring and measuring in a medical device Quality Management System (QMS)
  • The requirements in FDA’s QSR for calibration
  • The requirements of ISO 13485:2003 and ISO 13485:2016
  • The distinction between “accuracy” and “precision”
  • The role of traceability in a calibration program
  • The audit tasks in both QSIT and MDSAP
  • And much more!

Drawing on actual warning letters, data from FDA’s Quality System Inspection Technique (QSIT) and the Medical Device Single Audit Program (MDSAP) Audit Model, Mr. O’Leary spells out FDA requirements for control of inspection, measuring and test equipment; IM&TE in the Quality System Regulation (QSR); ISO 13485:2003, and ISO 13485:2016.

Special Bonus Material: Participants receive a checklist with the requirements from FDA QSR, ISO 13485:2003, and ISO 13485:2016.

Device defects lead to warning letters, lawsuits, liability ... and, in the worst case, patient deaths. Why take such a risk when it’s so easy to get up to speed on this important area of manufacturing quality?

This presentation is for individuals involved in the calibration program for device manufacturing and design. The following job roles may especially benefit:

  • Quality Managers
  • Quality Engineers
  • Production Managers
  • Production Supervisors
  • Manufacturing Engineers
  • Production Engineers
  • Design Engineers
  • Process Owners

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.