Product Avatar Image

Cognition

Show rating breakdown
15 reviews
  • 3 profiles
  • 3 categories
Average star rating
4.5
Serving customers since
1996
Profile Filters

All Products & Services

Product Avatar Image
Cognition Compass MED

15 reviews

Compass is a pre-configured, out-of-the-box, SaaS solution purpose-built to connect data across all functional areas of medical device product development, leveraging regulations such as 21 CFR 820.30 as well as standards ISO 13485, IEC 62366, and ISO 14971 as the foundation of the software design. It enables compliant product development by ensuring the process of authoring, reviewing, and releasing is enforced via workflows and built-in document templates, and automates a complex workflow between those interconnections to ensure compliant development. It provides an adaptable set of document templates for the entire product design control process from user needs to validation, with a focus on risk, requirement, and test management. Saving time and resources, it maintains documentation and supports submissions as well as provides automatic generation of the master trace matrices and documents for the Design History File (DHF), Technical Documentation Records, or audit support. Compass is best suited for small- to medium-sized medical device companies looking for guidance on how to bring their products to market with less risk. Compass offers guided compliance that is fully functional out of the box.

Product Avatar Image
Cockpit Platform

0 reviews

The Cockpit Platform is a validatable environment for product development. Cognition offers the Cognition Validation Kit, which enables companies to confirm the validation of the Cockpit Platform against GAMP 5 and AAMI TIR36-2007. You can either validate on your own or use Cognition's Validation Services to ease the burden

Product Avatar Image
Cognition

0 reviews

Cognition is an applied AI lab dedicated to advancing software engineering through artificial intelligence. Their flagship product, Devin, is the world's first AI software engineer, designed to collaborate with engineering teams to enhance productivity and innovation.

Profile Name

Star Rating

11
4
0
0
0

Cognition Reviews

Review Filters
Profile Name
Star Rating
11
4
0
0
0
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.

About

Contact

HQ Location:
Lexington, MA

Social

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