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Featured Articles

June 2010

Denise Dion

The Four Pillars of QSR Compliance

Denise Dion
Senior Consultant, EduQuest, Inc.

At first glance, FDA's Quality System Regulations (QSR) for medical devices - contained in 21 CFR 820 - may make your eyes cross and your stomach churn. The rules are intimidating, yes - but impossible to follow, no. Like the old proverb says, the way to eat an elephant is one bite at a time, and the way to comply with the QSR is to break down your quality system into bite-size chunks, which FDA has conveniently labeled "subsystems."

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Dan O'Leary

Process Validation for Medical Devices

Dan O'Leary
President, Ombu Enterprises, LLC

Process validation is an essential part of medical device manufacturing but doesn't always receive the attention it deserves (and requires). The regulations provide the requirements (FDA QSR 820.75 and ISO 13485 7.5.2), but often manufacturers don't completely understand them and don't fully implement them. The consequences can be audit findings from a Notified Body or Inspectional Observations on an FDA 483.

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David S. Brown

Validation of Off-the-Shelf Software

David S. Brown
President of David S. Brown LLC, A Consulting Firm

While there is extensive guidance and documentation available for the development and validation of proprietary software, there is relatively little guidance available for the validation of commercial off-the-shelf software (OTS). The FDA's guidance document for software development, while somewhat dated (2002), provides some general guidance (including reference to general principles of software development) and references to additional guidance documents for software used in production and processes.

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Did you know that according to a recent FDA news release, "FDA Changes Process for Medical Device Advisory Committees," the FDA will be changing the way in which medical devices are reviewed and approved for market sale?
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