Risk Management is necessary to ensure device usability, safety, and regulatory compliance. FDA’s quality system regulation is intended to give manufacturers “the flexibility to determine the controls that are necessary to be commensurate with risk.” FDA does not define what risk analysis method should be used, only that some method must be used in the design phase. The Cockpit Platform provides numerous methods for risk analysis including, but not limited to, Preliminary Hazard Analysis (PHA), Fault Tree Analysis (FTA), and numerous forms of Failure Mode Effects Analysis (FMEA). FDA recommends following the ISO 14971 standard for Medical Devices – Application of risk management to medical devices.
Risk Management Methods with the Cockpit Platform
The Cockpit Platform provides a number of risk management methods that are approved for use in ISO 14971 and IEC 62366.
Preliminary Hazard Analysis is easy with Cognition’s guided template for compliance. The template guides product teams through the process of fully completing a PHA exercise, jump-starting them on the path to submission.
Human Factors Engineering
According to FDA, Human Factors and Usability Engineering is the idea of understanding “how people interact with technology and studying how user interface design affects the interactions people have with technology.”
The Cockpit Platform provides mechanisms for completing numerous types of Failure Mode Effects Analysis depending on the product team’s needs. We provide pFMEA, dFMEA, FMECA, and many others out-of-the-box. With the help of Cognition’s engineering team, any number of other types of FMEAs can be created for use within the platform.
Fault Tree Analysis is a probabilistic risk analysis used during product development. The Cockpit Platform supports this analysis by providing a built-in, graphical method. FTA handles both pre- and post-mitigation probabilities and supports numerous calculation methods including, but not limited to, basic-gates, AND, and OR gates.
Cognition provides multiple templates to ensure regulatory compliance.
Cognition’s powerful guided approach to regulatory compliance is a combination of the base Cockpit Platform and a specialized set of templates created for specific standards. Cognition offers a template to complete the PHA exercise recommended in ISO 14971. Download our white paper to learn more:
Risk Management Features
- Detection Levels
- Occurrence (Probability) Levels
- Severity Levels
- Score Settings: Simple Calculations vs. Configurable Score Matrix
- Color Settings: Simple Threshold vs. Configurable Color Matrix
Connect other programs to Cockpit to transfer data between the two. The possibilities are endless.
Easily allocate design inputs, user needs, etc. to sub-systems of the design.
Cockpit’s built-in reporting and report creation abilities allow teams to gather information on anything.
EVERYTHING IS LINKED
From risks to mitigations to requirements to tests and more. Everything is linked and stored in the same Cockpit database.
Manage all aspects of requirements and their connections within the platform.
VERIFICATION & VALIDATION
Manage all verification and validation tests for your design. All tests are dynamically linked to one or more requirements, creating a documented trace.