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.

  • Connector.Connector.

    PHA

    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.

  • Connector.Connector.

    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.”

  • Connector.Connector.

    FMEA

    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.

  • Connector.Connector.

    FTA

    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

The Cockpit Platform provides configurable risk settings out-of-the-box. Change severity, detectability, and occurrence values for the entire site or for an individual project. Teams can also configure whether to use simple calculations for both color and score or they can configure custom matrices based on company standards. The configurable settings include:

  • Detection Levels
  • Occurrence (Probability) Levels
  • Severity Levels
  • Score Settings: Simple Calculations vs. Configurable Score Matrix
  • Color Settings: Simple Threshold vs. Configurable Color Matrix

risk_settings

The Cockpit Platform provides the powerful ability to create libraries to use among product development lines. These libraries can contain any sort of object, such as Harms and Hazards for risk management processes. These libraries are configurable by your organization and are access controlled, only allowing those authorized to access and edit the libraries.

 

library_picker
The Cockpit Platform provides a number of out-of-box and configurable risk analysis tools, such as FMEA (d/u/p), PHA, and FTA. In all formats, the platform will automatically calculate risk scores within the table based on the settings configured during the platform initialization. The team can choose which scoring method to use during risk analysis. Some out-of-box scoring methods for FMEA and PHA include, but are not limited to: RPN, SxO, Mitigation Benefit, and Residual Risk. FTA calculations include pre- and post-mitigation risk.

fmea_scoring

OPEN API

Connect other programs to Cockpit to transfer data between the two. The possibilities are endless.

ALLOCATION MATRICES

Easily allocate design inputs, user needs, etc. to sub-systems of the design.

DETAILED REPORTING

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.

REQUIREMENTS MANAGEMENT

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.