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Cognition

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15 reviews
  • 1 profiles
  • 1 categories
Average star rating
4.5
Serving customers since
1996

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Star Rating

11
4
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Cognition Reviews

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Profile Name
Star Rating
11
4
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Bijan E.
BE
Bijan E.
Award-winning Medical Device Risk Mgmt Author, Professor, and Consultant
10/31/2024
Validated Reviewer
Verified Current User
Review source: Organic

Compass Med is a well thought-out SW product

Flexibility and convenience. You can customize the SW to your liking, or just use the built-in functionality to meet most of your needs.
Verified User in Biotechnology
AB
Verified User in Biotechnology
10/28/2024
Validated Reviewer
Review source: Organic

Thorough Traceability

The ability to link data completely throughout all documents.
Antonio D.
AD
Antonio D.
10/23/2024
Validated Reviewer
Verified Current User
Review source: Organic

Compass used to submit technical documentation of a medical device to US FDA

I met Compass when I needed to submit the technical documentation of a medical device to the US FDA and it was a success: this was possible thanks to both the structure of the software and the excellent technical support that supported me throughout the learning phase of the platform. Coming to the structure of the platform, Compass effectively and solidly addresses the three large key areas related to the development of a device, namely the definition of requirements, the risk analysis and the verification and validation phase of the requirements. I find that the use of the platform is made clear by the structure that has been developed with the needs of developing a medical device in mind and this makes it easy to use. A feature that I particularly like about Compass is the traceability matrix that is automatically generated between all the design requirements: User needs, Design input and Design output. In the same traceability matrix, next to each requirement, the relative verification or validation test is linked and this makes the whole picture of the project very clear and easy to explore. Furthermore, Compass is also very well suited to customizations and the technical support has always satisfied our needs.

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HQ Location:
Lexington, MA

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What is Cognition?

Cognition Corporation, headquartered in Lexington, Massachusetts, specializes in product development and compliance solutions for the life sciences industries. Our solutions focus on enhancing efficiency, quality, and compliance throughout the development process. For medical device companies, Cognition offers a design controls software platform, Compass MED, that helps meet regulations faster with real-time traceability, guided design controls, and change once, update everywhere functionality – turning manual and disconnected data into structured submissions that enable them to get to market faster. For pharmaceutical companies, Cognition’s Compass BIO software suite of applications for CMC module 3 reports —specifically created for pharma, biotech, and CDMO companies—is an innovative, technically driven digital CMC software solution to help biopharmaceutical companies navigate, organize, and generate the complex data tables and reports required for data management of projects and regulatory submissions without requiring manual data transcription and extensive data integrity checking. Compass BIO supports both large molecule (biologics) and traditional small molecule products. Unlike other solutions that simply replicate traditional documents and spreadsheets, Cognition takes a structured data approach so you can easily build relevant connections between data items, automatically create complex trace matrices and data tables, and export formatted documents instantly – offering a more efficient and integrated solution. We are shifting the data management landscape for life sciences product development from a static, document-based approach to a dynamic, information-driven approach helping to streamline and alleviate the administrative burden of product development documentation. Further information about Cognition Corporation can be found at www.cognition.us.

Details

Year Founded
1996
Website
cognition.us