ForgeComply is the AI execution layer for compliance in regulated hardware. Replace 6-figure consultancy bills with software output in days.
Sustaining engineering teams “can basically only manage to do regulation fixes and updates” — there’s no headroom for cost-downs, performance improvements, or design refinement.
Director of Systems Engineering, multi-site Medtech mfr
Compliance work is consuming 20–30% of engineering capacity at scaling Medtech companies. And there is no in-house tool that fixes this.
Compliance is “a major painpoint slowing the business down and sucking in resources.”
Compliance lead, regulated hardware mfr
So you spend $200–400K per submission on regulatory consultancies. Expensive. Episodic. Knowledge walks out the door when the engagement ends.
You hired engineers to design products. They’re spending half their time assembling evidence.
By the Numbers
0–0%
Engineering capacity consumed by compliance work at scaling Medtech companies.
Reported pain across customer-discovery interviews, 2026.
$0–0K
Per active submission spent on regulatory consultancies.
Industry pattern across Medtech, vape, and life-sciences instrumentation.
0–0 months
Launch delay from failed audits.
Every regulated-hardware company has felt this.
ForgeComply replaces this with software output in days.
How it Works
ForgeComply builds a live graph of your requirements, risks, tests, suppliers, and standards — then reasons across it the way a senior regulatory engineer does, but in seconds rather than weeks.
Forge has read every FDA decision in your category. Every standards clause. Every prior submission.
Your engineers ask in plain language. Forge cites the precedent.
Pull in requirements, risks, tests, suppliers, design history. Forge sits above your existing tools — no migration, no rip-and-replace.
The moment your product context connects, Forge maps every applicable standards clause, generates the evidence inventory, and flags every gap. No waiting. No prompting. When you want to dig deeper, ask follow-up questions in plain language — Forge cites the standards and the product nodes it grounded the answer in.
[FORGE] Auto-analysis complete · 12,847 clauses indexed [FORGE] 47 applicable to your product · IEC 62304, ISO 14971, FDA 510(k) [FORGE] Evidence coverage: 31 / 47 (66%) · 16 gaps flagged > Show me the highest-risk gaps with no current evidence [FORGE] 3 gaps in IEC 62304 §5.5 (Software Unit Implementation) [FORGE] · No unit test evidence for module fw_control v2.3 [FORGE] · Risk control measure 4.2 not traced to verification [FORGE] · §5.5.4 acceptance criteria not documented > Generate the verification protocol for fw_control v2.3 [FORGE] Protocol draft ready · 4 test cases · 2 standards references
Forge’s outputs are probabilistic risk values, not binary verdicts — the AI shows you how confident it is, where the gaps are, and what evidence is missing. You stay in control.
Standards update. Products evolve. New markets open. Forge reasons across changes in real time and flags impact, so submission prep takes days, not quarters.
Capabilities
Six capabilities, all built on the same product context graph. Each one removes a piece of the velocity tax.
AI maps applicable standards across territories, regimes, and product classes — no 200-page PDF and a highlighter.
Forge identifies which clauses apply to your specific product — and explains why, with citations.
An actionable list of what’s missing for your submission — built into your design history, not a separate audit doc.
Instantly generate test plans for internal teams or external test houses. Updated whenever requirements change.
Standards update; Forge knows. Get flagged on changes that affect your product — not every bulletin.
A coherent, traceable evidence package for 510(k), MDR, or PMTA — with provenance baked in.
All built on the Product Context Graph. The more you use it, the sharper it gets for your specific product.
Why Forge
You’ve probably tried — or are paying for — one of these. Here’s why Forge is different.
Audit-first, AI-bolted-on
Chat without context
Engineering velocity, audit-grade evidence
All three options will live in your stack for a while. The question is which one drives the work.
Who’s Building This
Forge AI is led by an engineering team with 15+ years of combined experience building regulated hardware products — from concept through global certification and mass production. We’ve lived the pain on the inside: the design reviews that stall because the evidence isn’t traced; the submissions that slip because the team is buried in paperwork. ForgeComply is what we wished existed back then.
Frequently Asked
The FDA doesn’t reject documents based on how they were authored — they accept evidence based on traceability, reproducibility, and the validity of the underlying claims. ForgeComply attaches provenance to every AI-generated output: which standards clauses, which product-context nodes, which evidence sources. A reviewer can audit the chain. The bigger risk is the opposite — submissions assembled by humans without full traceability across a sprawling document corpus.
Yes — Forge sits above your existing storage, not in place of it. Documents stay in Confluence, SharePoint, Teamcenter, Windchill, or Google Drive. Forge reads them, builds the Product Context Graph above, and lets your team query and edit through Forge while the source-of-truth files don’t move. No migration, no rip-and-replace.
We’re on the standard path: SOC 2 Type I underway, Type II next; GAMP 5 / 21 CFR Part 11 readiness on the roadmap and required for our Medtech go-to-market. Happy to share our current security and validation posture under NDA during a demo conversation.
Each customer’s Product Context Graph is fully isolated at the data and compute layer. AI inferences run within the customer’s tenant boundary; no cross-tenant data leakage, no model training on customer data without explicit opt-in. Full architecture detail under NDA.
PLM systems are systems of record — they store the product. Forge is an execution layer — it reasons across the product. The two coexist: Teamcenter holds the parts, the BOM, the change records; Forge connects to it, reads the live state, and answers questions about compliance impact, evidence gaps, and submission readiness. We’re additive, not replacement.
We’re working with a small group of design partners across Medtech and regulated hardware. We’re deliberately tight on the partner list until we’ve shipped the next major milestone — book a demo to see if Forge fits your team and your timeline.
30 minutes. You walk us through a current submission or compliance pain. We show ForgeComply running against a representative product context (yours, anonymised, if you’d like to share). You leave with a clear answer on whether the tool maps to your specific regulatory regime and submission timeline. No pricing pitch, no “next-step” pressure.
Book a Demo
30 minutes is all it takes to see whether ForgeComply maps to your stack and your submission timeline.