We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Home » Store » Device Books » Medical Device Calibration: A Step-by-Step Guide to Meeting FDA and ISO Standards
Other Options
PDF Edition
$197.00
PDF Edition - 3-4 Copies (10% Off)
$177.00
PDF Edition - 5-6 Copies (15% Off)
$167.00
PDF Edition - 7-9 Copies (20% Off)
$158.00
PDF Edition - 10+ Copies (25% Off)
$148.00
Medical Device Calibration: A Step-by-Step Guide to Meeting FDA and ISO Standards
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.
Order Your Copy Today
PDF Edition
Available Format
PDF Edition — $197
Who Will Benefit
Quality Managers
Quality Engineers
Production Managers
Production Supervisors
Manufacturing Engineers
Production Engineers
Design Engineers
Process Owners
Multi-user Access
Save money with a license agreement allowing significant numbers of users access to an electronic version of this book. For multi-user access to multiple titles, FDAnews offers the FDAnews Online Library — a personalized collection of FDAnews publications that is fully searchable. Contact Customer Service for a quote or more information.
Our Guarantee
Not satisfied with your publication? For the PDF version, you must notify FDAnews within 24 hours of receipt of purchase and we will refund 100 percent of your purchase price.
