Risk analysis for medical devices based on the OMG RAAML specification
- Significant documentation effort to gain certification
- Today, document driven development approach
- Risk management (RM) activities are a cost driver
- Lack of standardized methods and practices to qualify medical equipment
- RM information-wise decoupled from engineering
- Provide a standard based method implementation for RM
- Enable integration of RM into engineering activities
- Comply with RAAML language and philosophy
- Enable MBSE
- ISO 14971:2019 – Medical devices – Application of risk management to medical devices
- IEC 62304:2006 – Medical devices software – Software lifecycle processes
- IEC 62366:2015 – Medical devices – Part 1: Application of usability engineering to medical devices
- IEC 60601:2006 – Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
- RAAML 1.0 – Risk Analysis and Assessment Modeling Language
- SysML 1.6 – Systems Modeling Language
- UML 2.5.1 – Unified Modeling Language