Medical Device Risk Management
ISO 14971 Risk Management Software for Medical Devices
Medical device teams need risk management workflows that connect device context, hazard analysis, risk controls, requirements, evidence, and review history. ISO 14971 work becomes difficult to defend when risk files and approval decisions are spread across documents, spreadsheets, and ticketing tools.
Aegis SafeForge helps teams structure medical-device risk management with AI-assisted drafting, controlled review, and traceability from hazards and risks to risk controls and supporting evidence.
Domain challenge
The medical-device safety challenge
Risk management files need to stay current as device context, software behavior, requirements, risk controls, and evidence evolve. Teams need reviewable records instead of disconnected risk tables.
SafeForge workflow
How Aegis SafeForge helps
- Capture device context and supporting knowledge before risk analysis begins.
- Structure hazards, risk records, controls, requirements, and evidence with clear approval state.
- Keep traceability visible for engineering review and audit preparation.
Supported medical-device workflows
Frequently asked questions
What is ISO 14971 risk management software?
ISO 14971 risk management software helps medical-device teams identify hazards, estimate and evaluate risks, define controls, and maintain traceability in a risk management file.
Does SafeForge create the risk management file automatically?
SafeForge supports structured drafting and workflow management, but engineers remain responsible for review, approval, and final risk decisions.
Can SafeForge link risks to controls?
Yes. The platform is designed to connect risk records to controls, requirements, evidence, and review history.
Is AI appropriate for medical-device risk work?
AI can support drafting and structuring, but regulated risk decisions require human review, controlled evidence, and traceability.
Who should use SafeForge for medical devices?
Safety, quality, systems, and software teams working on structured medical-device risk management can use the workflow foundation.
See the workflow
Review SafeForge against your current safety process
Bring one real workflow bottleneck: HARA, TARA, requirements traceability, artifact generation, review control, or audit-ready evidence. We will map how SafeForge would fit your team.