Medical devices · 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.
The 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.
With ASF Core
How Aegis SafeForge helps
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.
- 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.
Industry profile in ASF Core
- Medical devicesISO 14971 · IEC 62304 · IEC 81001-5-1Risk analysis, risk controls and evidence
FMEDA captures inputs and external analysis references; ASF does not calculate PMHF. The value is shown as not computable, with the reason. Safety case, confirmation review, functional safety audit and assessment, configuration baseline and safety release are available as manually maintained work products, without AI generation. Supplier, tool-confidence, reuse and field records support recording and review, without automated qualification or release. Industry profiles do not imply certification or tool qualification.
Supported medical-device workflows
Device definition · Risk analysis · Risk controls · Requirements traceability · Evidence review
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FAQ
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 Aegis SafeForge create the risk management file automatically?
Aegis SafeForge supports structured drafting and workflow management, but engineers remain responsible for review, approval, and final risk decisions.
Can Aegis 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 Aegis SafeForge for medical devices?
Safety, quality, systems, and software teams working on structured medical-device risk management can use the workflow foundation.
Compare ASF Core with your current process.
Bring one real bottleneck: HARA, TARA, traceability or evidence. We will show how ASF Core fits your process.