domain-healthcare:medical-device-software

What problem does it solve?

This Skill provides comprehensive guidance and structured information for developing medical device software in compliance with stringent regulatory standards like IEC 62304 and ISO 14971, ensuring safety and market readiness.

Core Features & Use Cases

• Regulatory Compliance: Understand and apply IEC 62304 software lifecycle processes and ISO 14971 risk management.
• Documentation Planning: Identify essential documentation for regulated software projects, including SDP, SRS, SAD, and traceability matrices.
• Risk Management: Perform hazard analysis, build risk management files, and apply the risk control hierarchy.
• Design Controls: Structure design inputs, outputs, verification, and validation for FDA submissions (510(k), PMA, De Novo).
• Cybersecurity: Address FDA premarket cybersecurity guidance, including SBOM generation and vulnerability management.
• Use Case: A startup developing a new Class B medical device needs to understand the required documentation and risk management activities for their software. This Skill provides the framework and references to guide them through the process.

Quick Start

Explain the software safety classification process according to IEC 62304.