Build Safer, Compliant Products
Building medical devices is a privilege that comes with inherent risks. Devices have a direct and immediate impact on the longevity and quality of life for patients. Whether we realize it or not, we all know someone who benefits from a medical device. As engineers, designers, developers, scientists, and manufacturers we take our responsibility to our end customers seriously. Part of our responsibility is ensuring the safety and efficacy of our devices. Designing safe devices is a base level requirement that goes without saying. This is why Cognition built Compass
Our Risk-First Approach
Our risk-first approach places an emphasis on comprehensive risk analysis and its integration into the design control process so that all risks are identified and considered. We tightly integrate risk with requirements and testing to ensure quality is integral throughout all phases of product development – enabling companies to deliver safer, compliant products to market faster.
"Our post-market surveillance identified a particular rate of harm was actually higher than what was currently documented in our Hazard Analysis. With Cognition, that update was able to be instantly applied to not only the hazard analysis document, but also auto-update the risk index value in three dFMEAs, ten pFMEAs, and five design verification protocols"
INTERVENTIONAL MEDICAL DEVICE COMPANY
Guided Risk Management Supported by Regulatory Standards
Compass has the ability to embed global and/or regional regulations and standards to guide the user through the risk analysis process. Compass poses simple questions and uses the answers to auto-populate risk analysis tables.
Why it matters: Working directly from standards and regulations, like ISO 14971 or EU MDR, is the most efficient way to achieve rapid compliance. Using standards and regulations as a starting point means your technical documentation (i.e., Design History File (DHF), Annexes I and II, etc.) is audit-ready, submission-ready, and easily supports process inquiries.
Risk-First Design Thinking
In other regulatory prep tools, risk management is not a native integration. Compass, on the other hand, was built with 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.
In Compass, you are guided through the process of creating a:
- Risk Management Plan
- Preliminary Hazard Analysis
- Use Error Analysis
- Design FMEA
- Design Risk Analysis
Why it matters: Each risk task must be addressed individually since the goals of each task are fundamentally different. However, it is imperative that they are all integrated and tell a cohesive story of how the device is designed for safety, and what controls are in place to ensure that safety.
Sequence of events management
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.
Why it matters: Our extensive research shows that connecting FMEA and Risk Analysis through the Sequence of Events component allows you to maintain the work done in FMEA while identifying control measures to be reused in the risk analysis assessment should they effectively contribute to lowering the risk. This method, in our view, is the right approach to complying with ISO 14971. To dig deeper, read the article published in MDDI, “Complying with ISO 14971:2019,” by our Compass Product Line Manager, Ben Higgitt.
Integration of Risk, Requirements, and Testing
Risk control measures must be implemented into the design to control the risk. In Compass, risk management and requirements management are tightly integrated, along with test management, this enables real-time assessment of the impact of every change across every function.
Why it matters: Analyzing risk in isolation is not enough. Risk control measures must be implemented with a clear, traceable, audit trail.
Why choose Compass for Risk Management?
Compass was developed for teams that want to go above and beyond regulatory compliance and build safe and innovative devices that truly have a profound impact on the lives of their patients. Compass risk management functionality was developed by Cognition with a decade of experience with our enterprise solution, Cockpit, working with the largest companies in the medical industry on best practices. Our risk-first design thinking makes it easy for companies of any size to implement and realize the benefit of a more comprehensive approach to risk management
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