Guided Compliance® To Bring Safer Products to Market Faster

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.


Learn why companies are leaving Excel and Word in the past and switching to Compass for product development data management. 


COmpass Core Functionality

Compass Standard Functionality

What Our Customers Are Saying ABout Compass

What Sets Compass Apart

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Regulatory Compliance Is Not Optional

Compass SUpports Compliance with Major Industry Standards and Regulations. 

Why Do Leading Medical Device Companies DEPEND Compass?

  •  A Unifying Solution - unifies your data into one system which enables you to focus on developing and not on maintaining or updating data and relationships.
  •  Data Integrity - provides a “single-source of truth” for every data item - if a requirement is changed in the product requirements document for example, it is automatically updated throughout.
  •  An Extension of Your Team - a customer-first approach to supporting and engaging with our customers. When you choose Cognition you are getting more than a SaaS solution for product development you are getting a team of developers, engineers, and industry-focused experts who are here to support and guide you beyond the sale.

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See How Compass Can Help You Get to Market Faster, With Complete Traceability.