
Cockpit® Enterprise
Maintain a single source of truth with structured data for your
medical device product Development
Cockpit Enterprise is our software application for medium to large medical device product development teams that integrates requirements management, test management, risk management data, and more, in a unified environment. Cockpit Enterprise is highly configurable and can be personalized to meet a company’s needs. It has a rich development framework that allows organizations to implement their Standard Operating Procedures (SOPs) and Work Instructions (WIs) in a controlled and auditable environment. Ultimately, Cockpit Enterprise helps medical device manufacturers of Class II and Class III devices author, review, and approve the documents required for regulatory submissions and audits.
Cockpit Enterprise is best suited for mature organizations that have established standard operating procedures and can dedicate the necessary resources to configuring and deploying the system.
Core Capabilities

Key Features
Cockpit Enterprise has many individual features that support product development teams in their endeavor to develop safe and effective products. This list below represents the most valued features as reported by Cognition’s customers.
What Our Customers Are Saying About Cockpit Enterprise
" I can’t say enough good things about the team and the attention we get. The people at Cognition want us to do well and are extremely responsive to us. Cognition is an excellent software vendor partner."
- Medical Instrumentation Supply Company
" With Cockpit Enterprise we manage our data, create our documents, review and approve them, then export them to our official system of record. For us, Cockpit Enterprise is an automated DHF document authoring tool."
- Implantable Medical Device Company
" Our Systems Engineering team owns the product development process and is at the center of it, but, by using Cockpit Enterprise we have allowed other groups to gain access to the electronic environment and make their contributions independently. For example, our Marketing team was able to log in and write their own user needs."
- Medical Diagnostics Company
" I have seen other tools that create a spreadsheet-like risk table in an attempt to check the box for risk management, but in my experience those risk capabilities are not data driven like in Cockpit Enterprise. A huge differentiator for Cockpit Enterprise is the ability to manage the Risk Chain."
- Orthopedic Medical Device Company
" Before we had Cockpit Enterprise, the problem we faced was that when I went to update document A, I really needed to update document B as well. So, you end up with a change process which attempts to get people to do this manually. In Cockpit Enterprise I no longer have to do that, changing document A automatically changes document B. In the old way the changes may never show up, which would end up in a potential CAPA situation."
- Interventional Medical Device Company
" What has given us success is our ability to create and develop templates that precisely meet, requirement-for-requirement, our quality system - that’s huge! We have configured Cockpit Enterprise based on the foundation of our global quality system, and our templates have been validated to meet our global work instructions."
- Minimally Invasive Medical Device Company
Why Do Leading Companies Choose Cockpit Enterprise?
- Enterprise Level Configurability - results in a robust system that allows for maximum efficiency and accuracy when developing new products.
- 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.
- Industry Leading Risk Management - break free from the confines of isolated, 2-dimensional spreadsheets for a risk-first approach that places high emphasis on the value of tightly integrating risk management in the design control process with requirements and tests.
- Cross-Functional Integration - collaborate effectively and develop in unison, with a full view of the entire development environment.
- Dynamic Document Authoring that is Submission Ready - combines database style functionality with document authoring, reviewing, and approving.
- Open Platform for Integration - easy to use REST API and off the shelf integrations with outside tools such as Jira, Sparx Enterprise Architect, and Microsoft DevOps.
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See How Cockpit Can Help You Structure Your Data and Create a Single Source of Truth.