Cockpit Crew Blog

Cockpit Compliance, Authority in Medical Devices

Today we are talking about Cognition’s Cockpit platform, and how it will lead your company closer to compliance with its easy-to-use, online, guided templates. One of Cockpit’s key features is helping medical device companies comply with 21 CFR 820.30. Our templates provide a master trace table which allows teams to see the connections from user needs all the way through to Verification and Validation work and testing. Cockpit provides complete end-to-end traceability for your device automatically as your engineers work.

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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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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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Michelle's Moment: FDA FY2015 Plan for Guidance Document Development and Review

Pulse Check: FDA FY2015 Plan for Guidance Document Development and Review

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Michelle's Moment: New FDA Guidance: LATEX FREE?

Michelle's Moments: New FDA Guidance - Latex Free?

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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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Compliance Webinar: What the FDA Was Up to While You Were on Vacation

What the FDA was doing while you were on vacation this summer.

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Michelle Lott Joins Cognition!

Cognition is proud to welcome Michelle Lott as our Executive Advisor for Regulatory Strategy.  Michelle’s input will help Cognition better understand regulatory requirements, the ever changing medical device industry standards, and the unique solutions that Cognition’s products like Cockpit provide. Cognition will leverage Michelle’s regulatory expertise in product commercialization to customize regulatory solutions and messaging throughout our software products. Michelle will coach and mentor both internal employees and external customers, helping all understand the changing regulatory environment.

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