Cockpit Crew Blog

AAMI TIR36, More Fun with Validation

The AAMI Technical Information Report (AAMI TIR36:2007) is a standard that covers the validation of software for regulated processes. TIR36 focuses on the machines, software, and processes involved with manufacturing devices and other products. Medical device engineer David A. Vogel lays out strategies for medical device companies in their automated process software validations, and includes a bit of history of multiple standards like TIR36, in Medical Device Software Verification, Validation and Compliance. He has first-hand experience with the standard as he and 13 other specialists in the field worked for about 3 years to establish TIR36, which is structured around the idea that there are multiple tools and approaches available, but only the ones that apply to each software element and its intended use should be used for validations. “The problem of validating non-device software is that it is so broadly defined that no single method or tool will work for all circumstances,” he says. This group published examples of validation plans to show how their methods could be applied, so now they have established some guidance.

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The Global Unique Device Identification Database (GUDID)

FDA is establishing a unique device identification system to adequately identify medical devices through their distribution and use,” according to the FDA’s website. It is currently in the middle of a seven year undertaking, which started in 2013 and is expected to end in September 2020, called the FDA Global Unique Device Identification Database (GUDID). It is an endeavor to mitigate clinical error and risk, while also yielding better data for a more robust post-market surveillance system. GUDID would also make product recalls more efficient in being able to pinpoint exactly the devices that went awry.

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