Medical Device Calibration: A Step-by-Step Guide to Meeting FDA and ISO Standards

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Medical Device Calibration
A Step-by-Step Guide to Meeting FDA and ISO Standards

Warning letter citing calibration failures are on the rise — indicating that the FDA is paying more attention to the issue.

Both the FDA and ISO have specific requirements for calibrating medical devices. And — they don’t always line up. So devicemakers doing business in the US and abroad need a clear path to compliance if they want to avoid penalties.

Medical Device Calibration: A Step-by-Step Guide to Meeting FDA and ISO Standards provides a roadmap that walks devicemakers through each aspect of calibration requirements — showing where the FDA and ISO differ and where they match up — and explains how to combine them to endure full compliance. A sample of the side-by-side approach is below:


QSR ISO 13485:2016
Ensure that all inspection, measuring, and test equipment, including mechanical, automated, or electronic inspection and test equipment, is suitable for its intended purposes and is capable of producing valid results. [§820.72(a)] Determine the … monitoring and measuring equipment needed to provide evidence of conformity of product to determined requirements [7.6]

Both documents contain requirements for the kind of equipment used to monitor and measure, but QSR is more detailed. Not only does it specify the types of equipment it covers, it takes the concept of suitability one step further than ISO 13485, requiring the equipment to be proven capable of returning results valid to their intended purposes.

“What this means,” O’Leary says, “is that your inspection measuring and test equipment has got to be in a calibration and maintenance program. That’s going to make sure that it produces valid results.”

Conclusion: Following QSR section 820.72(a) will allow you to cover ISO requirements at the same time.


You will learn:

  • The role of monitoring and measuring in a medical device Quality Management System (QMS)
  • Requirements for calibration in FDA’s Quality System Regulation
  • How to distinguish between accuracy and precision
  • The role of traceability in a calibration program
  • The audit requirements in both QSIT and MDSAP

The report defines key terms and concepts involved in calibration including proving that calibration practices can be traced back to recognized national and international standards.

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Who Will Benefit

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

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