
COMPASS®
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.
THERE is A BETTER WAY TO MANAGE YOUR DATA
Learn why companies are leaving Excel and Word in the past and switching to Compass for product development data management.
COmpass Core Functionality

What Our Customers Are Saying ABout Compass
"With Compass, we are confident in the consistency of our projects. We know our submissions will be a consistent package across our geographies."
- Combination Products Company
"Compass is like a skeleton - providing us the structure we need for medical device development and leaving us to populate the content into the right boxes. This allows us to focus on the content rather than the structure of the data."
- Biomedical Company
"Compass is very credible for consistency because it allows you to trace everything. The functional traceability allowed us to present to the FDA our device satisfying the requirements."
- Biomedical Company
"The capability to have all the requirements, risks, and tests in one place and in order is what drew us to Compass. We view Compass as a big container that is our project and within that container, there is everything we have designed about that project or device and we can be confident that the data is properly structured and updated."
- Biomedical Company
"If you have to make a change you are not going to make a mistake with Compass. You are not going to miss it like you may in Excel. You can see everything that is affected by the change.”"
- Combination Products Company
"I was very impressed with the support and engagement we received from Cognition starting with our first phone call. It was very apparent that they would be there for us beyond the sale. Once, we met Cognition team members and saw the Compass software, choosing Compass was a nobrainer."
- Consumer Products Company
"Compass saves us time. With Compass it is easy to create an overview trace that would be burdensome to create and nearly impossible to manage changes for using excel. When I make a change, I am confident that Compass will update the data throughout so I do not have to take time to confirm and can instead focus on creating the content"
- Biomedical Company
What Sets Compass Apart
Want to learn more about how Compass supports your product development compliance needs?
Regulatory Compliance Is Not Optional
Compass SUpports Compliance with Major Industry Standards and Regulations.
21 CFR Part 11
IEC 60812
IEC 62366
ISO 13485
21 CFR 820.30
ISO 14971
EUMDR
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.
Request a Demo
See How Compass Can Help You Get to Market Faster, With Complete Traceability.