Features
Everything ForgeComply does.
The pitch is on the home page. This is the depth — how Forge reads a product, maps every applicable standard, drafts the evidence, and keeps the whole operation current.
Capabilities
From product context to submission-ready evidence.
- 01
Standards mapping
Your applicable-clause matrix in hours, not weeks — across FDA 21 CFR 820, ISO 13485, IEC 62304, ISO 14971, EU MDR and more.
- 02
Clause analysis
Per-clause status across every applicable standard, each traced to the evidence that satisfies it.
- 03
Evidence gap analysis
Every gap flagged, each with a draft to close it, linked to the requirement and test it satisfies.
- 04
Automated test plans
Test plans generated and traced to the clauses they satisfy.
- 05 Live watch
Regulatory-change alerts
Forge watches the sources. When a standard changes, it walks your exposure and triages every affected certification.
- 06
Submission packaging
Evidence bundles assembled from the graph, submission-ready.
Prior approvals
Grounded in what regulators have already cleared.
Devices like yours have been cleared before — the pathway they took, the standards they cited, where they ran into trouble. Forge scans the public record (FDA 510(k), EUDAMED and more) and match-scores the closest cleared devices. Your pathway rests on real regulatory outcomes, not guesswork.
The full compliance operating system
And the machine around it.
One product graph underneath — requirements, risks, tests, suppliers, standards — with the operational depth a Quality organisation expects on top.
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Enterprise QMS
CAPA, management review, change control, training — with a 21 CFR Part 11 audit trail throughout.
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Per-clause checklists
AI-generated, evidence-linked, owner-assigned gap analysis.
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Labelling
Market-by-market labelling requirements traced to evidence.
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Regulatory pathways
Route-to-market analysis per target market, locked and tracked.
Coexistence
A reasoning layer, not another system of record.
Forge sits alongside the systems you already run — it doesn't replace them. Your QMS, PLM and Teamcenter stay authoritative. Forge connects to where your data lives, reasons across it, and hands its output back.
- QMS
- PLM
- Teamcenter
- Your data sources
Security & validation
Audit-grade by design.
Every output clears two independent layers of verification — an automated checking agent, then a qualified human's sign-off.
- Tenant isolation
- A complete, attributable audit trail
- Built to GAMP 5 and 21 CFR Part 11 principles
- SOC 2 Type I — active program (documentation under NDA)
Standards coverage
The standards Forge reads.
A growing library of the standards and clauses Forge maps to your product.
- IEC 60601-1
- IEC 62304
- ISO 14971
- ISO 13485
- EU MDR
- FDA 21 CFR 820
See it read your product.
30 minutes on a real product context — no pricing pitch.