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COMPASS® / COMPASS® PRO

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.

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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. 
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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 no-brainer.“
– 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

Template-Based, Out-of-the-Box Functionality

Compass can work for your business without requiring dedicated administration personnel devoted to configuration or customization, thus allowing you to focus on product development rather than administrative tasks. Compass offers pre-configured templates specific to medical device product development using our guided compliance approach. This means your product development process is documented in a submission-ready format.

Structured Data

Structured data contains specific information, each with a unique identifier. For structured data to be valuable, it may be used in multiple locations, exist over time, be reusable, be connected to child/parent/peers, and enable action at a distance. Given the unique ID setup, if you need to update the central property, the update will be pulled or pushed through to all locations that use it. This is exactly how Compass treats your product development data.

Structured data has many benefits, including:

  • Single Source of Truth
  • Increasing compliance
  • Reducing errors
  • Reducing time-to-market
  • Improving data integrity
  • Reducing resource costs
  • Reducing IT Burden
  • Increasing report quality
  • Preparing for the future
Industry-Leading Risk Management

Compass provides medical device companies an advantage with it’s risk-first 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. Compass takes a templated approach to risk management, guiding the user with simple questions and using the answers to auto-populate risk analysis tables.

Compass guides you through the process of creating a:

  • Risk Management Plan
  • Preliminary Hazard Analysis
  • Use Error Analysis
  • Design FMEA
  • Design Risk Analysis

Unlike other risk management tools, Compass not only manages individual risk data points, like hazards, hazardous situations, and harms, but it also manages the sequence of events that ultimately lead to a patient being harmed. While the individual risk data points can be stored in a library and reused, it is this unique sequence of events as a whole that must be mitigated against.

In order to best control risk, risk control measures must be implemented into the design. In Compass, risk management and requirements management are tightly integrated. In concert with test management, this enables real-time assessment of the impact of every change across every function.

For more on our approach to Risk Management in Compass, click here.

Traceability

Compass guides the development of best practice trace matrices with pre-configured templates – as design data is added, connections are automatically established. Once set up, when changes are made, objects are automatically promulgated across every connection in a trace. When a change has the potential to impact dependent relationships in the trace, those relationships can be easily identified for resolution. Compass trace matrices can be adapted to an organization’s SOPs and can be exported for reporting purposes.

Automated processes make it easy to apply quality best practices across the trace to ensure every change is accounted for and nothing falls through the cracks – a master map and single point of truth where all actions and their impacts across a product’s development lifecycle are recorded.

For more on our unique trace functionality, click here.

Designed Specifically for Medical Device Development

Submission Ready Document Export

Regulatory Compliance is Not Optional

COMPASS SUPPORTS COMPLIANCE WITH MAJOR INDUSTRY STANDARDS AND REGULATIONS. 
ISO 13485
ISO 14971
21 CFR 820.30
21 CFR Part 11
IEC 62366
IEC 60812
EU MDR
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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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