RISK MODULE FOR COCKPIT® ENTERPRISE
FLEXIBILITY AND SUPPORT FOR ISO 14971 IMPLEMENTATION IN MEDICAL DEVICE PRODUCT DEVELOPMENT
The Risk Module for our Cockpit Enterprise solution supports ISO 14971 implementation with the flexibility to align with existing processes at individual medical device companies, making it easier to address risk and deliver products to market.
The Risk Module extends the base-risk functionality included in Cockpit Enterprise, specifically to provide enhanced support for the array of ISO 14971:2019 risk management processes. It is designed to “plug in” to existing Cockpit Enterprise implementations, delivering new risk functionality without affecting existing requirement/test data. This gives users the control to specify data sources and object filters where required in order to connect the risk data to existing project data.
The Risk Module is an optional subscription add-on delivering new, supported functionality and UI elements for implementing risk/reliability analysis tools using the Safety Risk and FMEA Row classes, allowing users to start utilizing the risk functionality with minimal configuration needs.
The Risk Module for Cockpit Enterprise has the features and capabilities you need to address risk management and bring your products to market faster.
Risk Management Plan
- Easy access to change acceptability criteria
- Define at project level
Preliminary Hazard Analysis
- Ability to define questions similar to those from ISO 24971:2020 to assist in identifying Hazards
- Uncovers Situations, Justification for not applicable questions, Safety Characteristics, Initial Hazards, Side Effects
- Analyzes failures associated with the device
Product Risk Analysis
- Analyzes risks associated with the device as a result of side effects, failures, or use errors
aFMEA / Use Error Analysis
- Analyzes use errors associated with the use of the device
- Harms (with severities) are only sourced from a library
- New Hazards (local to the project) can be created or Hazards can be sourced from a library
WHY CHOOSE THE RISK MODULE FOR COCKPIT ENTERPRISE?
- Process Independence
- Faster Deployment
- Flexible Risk Environment Set Up
- Integrated Analysis and Reporting
- Workflow Availability
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