Best-in-class, guided risk analysis and structured data management enable medical device
companies to develop safe, regulatory-compliant products
Lexington, Massachusetts, USA – March 4, 2020 – Cognition Corporation, a leader in SaaS solutions for guided compliance in medical device and pharmaceutical product development, has released a new suite of industry-leading risk management functionality in its Compass® solution. Compass’ risk management feature includes guided risk analysis supported by regulatory standards, sequence of events management, and native integration with requirements and test management to ensure quality is integral throughout all phases of product development. Cognition’s risk-first approach places emphasis on comprehensive risk analysis and its integration in the design control process so that all risks, whether they are the result of a failure or not, are identified and considered.

“Risk analysis done properly is complex, as is managing risk within the design and development process; however, if not done properly, the result could be harm to the patient. That is why we’ve purposefully built software that makes it significantly easier for development teams to conduct a thorough, completely traceable, risk analysis that is tightly integrated with requirement and test management tools,” said Ben Higgitt, Compass Product Line Manager

Compass brings best-in-class functionality for better risk management and safer product development, including:

Guided Risk Analysis with Regulatory Standards and the Risk Management Plan
Compass guides users through the risk analysis process, and enforces policies based on regulatory standards like ISO 14971 and the project’s risk management plan. By developing products alongside standards and in accordance with an overall risk management plan, compliance can be rapidly achieved. By focusing on best practices, documents will be audit and submission ready.

Sequence of Events Management
Compass not only manages individual risk data points, like hazards, hazardous situations, and harms, but it also manages the sequence of events that could ultimately lead to a patient being harmed. Connecting individual risk data through a ‘Sequence of Events’ enables all risks, whether they are caused by a failure or not, to be identified and mitigated.

Native Integration with Requirement and Test Management
In Compass, risk management is tightly integrated with requirements and test management to assess the impact of every change across every function. This enables mitigations and controls to be
implemented with a clear, traceable, audit trail across all functions.

For more information on Compass’ risk management click here.

About Cognition Corporation
Cognition develops, sells, and supports risk-first product development and compliance solutions for the medical device and pharmaceutical industries and is trusted by the world’s leading life sciences companies. Its Software-as-a-Service platform enables customers to structure their data and automate processes with built-in quality to save time and money and bring products tomarket faster. For more information, visit www.cognition.us.

Press Contact:
Matt Burke
+1 603.315.0618
matt.burke@cognition.us

The new Compass® solution provides off-the-shelf, easy to use, template-based functionality to automate the product development process in compliance with industry standards and to bring products to market faster and with less risk.

Lexington, Massachusetts, USA – June 24, 2020 – Cognition Corporation, a leader in SaaS solutions for medical device and pharmaceutical product development, today launched Compass 2020. The new SaaS solution enables medical device product teams to automate and document the entire design control process—tightly integrating risk, requirement, and test management—with built-in quality processes. Compass guides development in compliance with standards such as ISO 14971, FDA 21 CFR 820.30, and ISO 13485 to speed product development. In beta since last year, the solution is now Generally Available (GA).

“For twenty years, Cognition has been building custom software implementations based on our Cockpit® platform for the industry’s largest medical device companies. Cockpit is optimized for large, complex projects where diverse data is interconnected and implementations are highly customized because requirements/SOPs are diverse.
Compass is based on the proven and powerful Cockpit technology and provides a prepackaged, templated product for medium-sized companies that do not have the time, resources, budget, or need for a fully customized solution,” explains Dale Gallaher, president of Cognition Corporation.

Compass provides template-based guided compliance through the medical device product development process and enforces quality processes across every connection. In addition, it provides a single point of truth so that when changes are made, they are made everywhere and potential effects of the change on other data are flagged. Compass enables small and midsize medical device companies to bring products to market faster while remaining in compliance with industry standards by combining automation with the most scalable trace matrices and most comprehensive risk management tools—all integrated with quality systems.

“Before introducing Cockpit/Compass, Mediso used requirement management tools, which provided little support in defining our processes. With Cockpit/Compass and Cognition, we instantly gained access to document templates, workflows, and a knowledge base, which guided us to perform our processes in better compliance with critical standards and good engineering practices. We were able to upgrade existing processes based on what we learned from Cockpit/Compass, and at the same time these tools could be fine-tuned to areas where we already had solid foundations. We expect that this solution will help us to better manage our modular product family, and so accelerate time to market—enabling Mediso, a relatively small company, to compete with the industry giants,” said Miklós Czeller, R&D Director at Mediso, a medical diagnostics company.

“Compass streamlines our product development processes, with complete confidence that we are in compliance with critical standards, by providing the needed templates to guide us in developing our LDT Software Platform. It provides a centralized environment for collaboration while ensuring that all data is correctly connected, with every activity and user action updated in real time across the process. Cognition’s solution ensures teams spend significantly more time focused on productive work, rather than building and maintaining documents and complex traces. This allows us to run lean and still accelerate our time to market more than any other solution I’ve had experience with,” said Chris W. Henry, Senior Manager, Software Quality Engineering at Epic Sciences, a medical diagnostics company.

Key features of Compass include:

• Integrated Risk Management: Industry-leading comprehensive risk management
  is tightly integrated with requirements and test management to provide real-time
  views of the impact of changes across the design process.
• Automated Design Controls: Step-by-step implementation of rigorous processes
  in design data and requirements management supports unlimited levels of
  requirements and the creation of Design History File (DHF) content.
• Test Management: Clearly connects testing to requirements that are linked to
  risk mitigation, closing the loop for risk control, and implementation.
• Scalable Trace Matrices: Supports the largest, most complex traces—with
  master trace matrices in excess of 10,000 items—and traces are automatically
  generated and updated when any changes are made.
• Document Management: Integrates predesigned workflows for easy review,
  approval, and release with auditable sign-off.
• Project Management: Real-time visibility into the status, activities, and detail of
  every aspect of the project.
• Software Validation: Validation kit includes test execution results for Compass
  out-of-the-box functionality, based on AAMI TIR36 and GAMP® 5 validation, and
  an optional validation services subscription plan to complete software validation
  based on specific use cases in your environment.

Compass has multiple use cases including speeding time to market, exiting remediation, creating Design History Files (DHF), and increasing compliance with standards like ISO 14971, 21 CFR 820.30, and ISO 13485. It provides real-time dashboards and connectors to popular tools like JIRA and GitHub. Compass is hosted in a fully secure environment, accessible 24/7, with guaranteed 99.9% uptime.

For more information on Cognition’s Compass Solution, click HERE.

To access the Compass press kit, click HERE.

About Cognition Corporation
Cognition develops, sells, and supports product development and compliance solutions for the medical device and pharmaceutical industries and is trusted by the world’s
leading life sciences companies. Its Software-as-a-Service platform enables customers to structure their data and automate processes with built-in quality to save time and money and bring products to market faster. For more information, visit www.cognition.us.

Press Contact:
Matt Burke
+1 603.315.0618
matt.burke@cognition.us