AI-powered cloud SaaS quality management system for medical device manufacturers.
8 compliance modules, AI risk intelligence, a regulatory AI assistant, 21 CFR Part 11 e-signatures, real-time KPIs — under ISO 27001 from day one.
- ISO 27001Certified development process from day one
- 21 CFRPart 11 e-signatures built in across all modules
- AIRisk intelligence with traceable regulatory citations
At a glance
- ClientA SaaS provider building the QMS that the medical device market was missing.
- ChallengeEight regulated domains, all interconnected, all critical to get right — plus AI that earns trust.
- Approach8 interconnected modules, AI grounded in regulatory text, signatures locked under audit trail.
- ResultsFrom spreadsheet patchwork to a single audit-ready compliance platform.
Medical device quality is one of the most regulated processes in any industry. Most teams manage it in spreadsheets.
FDA 21 CFR Part 820, ISO 13485, MDR and CE marking overlap and don’t forgive gaps, yet most small and mid-size manufacturers run quality on spreadsheets, shared drives and email.
The client wanted a cloud-native, AI-augmented QMS that quality managers could run without specialist IT, at the security bar its customers demand.
Building a QMS that only covers document management doesn't solve the problem.
Each module needed real workflow automation, and the AI had to be useful — not compliance theatre.
Breadth of regulatory coverage
Documents, Training, CAPA, Risk, Supplier, Audits, Change Control and Post-Market Surveillance, each with real workflow automation.
21 CFR Part 11 compliance
Every e-signature had to satisfy FDA rules on audit trail, signature meaning and record integrity.
Making AI genuinely useful in compliance
The AI had to flag risks quality managers act on and give guidance traceable to the correct regulatory source.
ISO 27001 delivery requirements
Device manufacturers must trust how their quality records are secured; certification was a customer expectation, not an option.
From spreadsheets to a full-compliance AI-powered QMS.
Document, train, investigate, assess risk, audit, control change, surveil — every module linked, because compliance gaps happen at the handoffs.
- 01Core modules
8 interconnected compliance modules with full workflow automation
A non-conformance in Document Management opens a CAPA automatically; audit findings trigger Change Control review; supplier issues feed Risk Management.
- 02Signatures
21 CFR Part 11 electronic signatures
Each signature carries authenticated identity, meaning, date and time, and an unalterable audit trail; signed records are cryptographically locked.
- 03AI intelligence
AI risk intelligence and regulatory AI assistant
The risk module reads risk records, CAPA history and post-market data; the assistant answers FDA, MDR and ISO 13485 questions, citing clauses.
- 04Visibility
Real-time compliance KPI dashboard and API integrations
Shows open CAPAs by age and severity, overdue reviews, training completion, audit findings, supplier risk; APIs expose records to ERP and EDC.
Nine modules covering document management through post-market surveillance.
- Document Management
- Training Management
- CAPA Management
- Risk Management
- Supplier Management
- Audit Management
- Change Control
- Post-Market Surveillance
- Real-time KPI dashboard
Eight modules connected. AI surfacing risk early. Audits trivial.
Eight modules. Complete lifecycle.
One platform covers every stage of the quality lifecycle: no side spreadsheets, no module gaps, no manual handoffs between systems.
ISO 27001 certified development process
The entire engagement ran under certification, so customers can trust the security of the platform holding their quality records.
21 CFR Part 11 compliant from day one
Every record is signed in an audit-traceable, cryptographically protected workflow that meets FDA electronic records requirements.
AI risk intelligence that acts early
Emerging risk patterns surface before they breach threshold, moving quality management from closing gaps to preventing risk.
From the team
The AI had to earn trust by being traceable, not just fluent. A regulatory assistant that gives confidently wrong answers is worse than no AI at all in a quality management context. Every AI response is grounded in the actual regulatory text and cites the relevant clause — quality managers need reliable guidance they can reference in an audit.
Stack
Built under ISO 27001; every AI answer cites the regulatory clause; signed records are cryptographically locked.
Building a regulated QMS or compliance platform?
We’ve shipped an ISO 27001-certified QMS with AI risk intelligence and 21 CFR Part 11 e-signatures. Worth a chat.
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