Bring Safer Products to Market Faster with Change Once, Update Everywhere Functionality

A Pre-Configured, Out-of-the-Box,
SaaS Solution

Compass® / Compass® PRO (collectively known as Compass) are pre-configured, out-of-the-box, SaaS solutions 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.

Compass 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.

What Our Customers are Saying about Compass® / Compass® PRO

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 no-brainer.”
– Consumer Health Care 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

There is a Better Way to Manage Your Data

Learn why companies are leaving Excel and Word in the past, and switching to Compass® / Compass® PRO for Product Development Data Management.

Access the Compass® /
Compass® PRO Demo Videos

Process-Based, Out-of-the-Box Functionality
Structured Data
Industry-Leading Risk Management

Compass provides medical device companies an advantage with its risk-focused approach that
places high emphasis on the value of tightly integrating risk management in the design control
process with requirements and tests. Compass supports the risk management process defined
in ISO 14971 and has the ability to embed global and/or regional regulations and standards
to guide users through the risk analysis process. The templates in Compass ensure process
consistency and enable stepping users through the process to produce comprehensive and useful
assessments. Risk becomes an active part of the development process with integration with
requirements and testing, not just a paperwork exercise to “check the box”.

Designed Specifically for Medical Device Development
Submission Ready Document Export
Compass® / Compass® PRO support compliance with major industry standards and regulations.

Our Products & Services

Why do leading Medical Device Companies depend on Compass® / Compass® PRO?

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® / Compass® PRO Can Help You Get to Market Faster, With Complete Traceability.