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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Michelle's Moment: FDA Case Study - Bringing Low to Moderate Risk Devices to Market

Pulse Check: FDA Releases Case Study Exemplifying How to Bring Low to Moderate Risk Devices to Market

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Compliance Webinar: Don't Forget!

Don't forgegt to sign up for the January Compliance Webinar with Michelle Lott, RAC.
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Reminder: January Compliance Webinar!

Don't forget to sign up for our upcoming January Compliance Webiar with Cognition's very own regulatory expert Michelle Lott.Topics this month include:

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Don't forget... Regulatory Webinar THIS WEEK!

Michelle Lott, RAC will be giving her second in a series of webinars overviewing changes to the regulatory playing field. Join us this Wednesday, November 19th, at 3:00PM EST for the October Regulatory Compliance Overview.

Click below to register:

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Catch Up With the Cockpit Crew!

Did you miss your chance to watch the first in the "Lunch with the Cockpit Crew" webinar? No need to worry, you can re-watch it now! Click below to watch the recording of the webinar Cockpit Engineer, Ryan Heide, held on Change Norification in Cockpit.

Lunch With the Cockpit Crew: Change Management Watch the Webinar!

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Watch the Webinar "What the FDA Was Up To..." Now!

Did you miss the first in a series of regulatory webinars? Do you want to watch it? Here is your chance! Click the button below to watch the recording. Also download the accompanying slide deck!

Watch the October Regulatory Webinar!

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