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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Catheters and Tomahawk Missiles, They Aren’t That Different—Are They?

Highly regulated environments. Endless piles of documentation to gain approval. Encounters with extremely strict, critical authorities that have the final say on the finished product going to market—or not. Most importantly, humans’ lives held at stake. Medical devices and submarines, they aren’t all that different...

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Michelle's Moment: Regulatory Guidance - Safety Considerations to Mitigate the Risks of Misconnection with Small-bore Connectors

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Michelle's Moment: Final MDDS Guidance Last in a Trifecta to Get Lower Classification Device to Market with Fewer Regulations

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Don't Forget About Our Upcoming Webinars!

The Cockpit Crew has three exciting webinars in the upcoming weeks! Be sure to register now so you don't miss them; even if you can't make the day, we will still send you a recording.
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Michelle's Moment: Regulatory Change - Moving Toward a National Medical Device Postmarket Surveillance System

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Michelle's Moment: Medical Device Single Audit Program to Ensure Regulatory Compliance

Pulse Check: Medical Device Single Audit Program (MDSAP) International Coalition Pilot Program

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Michelle's Moment: Regulatory Compliance - Patient Preference When Considering Risk-Benefits of New Device Approval

Pulse Check: Patient Preference When Considering Risks-Benefits of New Device Approval - Treatments for Obesity - FDA Voice: Listening to Patient's Views on New Treatments for Obesity

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Michelle's Moment: New FDA Draft Guidance - Medical Device Accessories

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