Cognition Corporation, a SaaS solutions provider for guided compliance in medical device and pharmaceutical product development, has released a new suite of 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.
Ben Higgitt, Compass product line manager, said: “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.”
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 focussing on best practices, documents will be audit and submission ready.
As well as managing individual risk data points, like hazards, hazardous situations, and harms, 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.
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.
