Ensure Device Usability, Safety, and Regulatory Compliance with Risk Management
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
Cockpit provides a number of risk management methods that are approved for use in ISO 14971 and IEC 62366.
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: