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How we built a full-compliance QMS covering 8 modules, with AI-driven risk intelligence, a regulatory AI assistant, 21 CFR Part 11 e-signatures, and real-time compliance KPIs — delivered under ISO 27001 certification from day one.
Quality management for medical device manufacturers is one of the most regulated and documentation-intensive processes in any industry. FDA 21 CFR Part 820, ISO 13485, MDR, CE marking — the regulatory frameworks are overlapping, demanding, and unforgiving of gaps.
Yet most small and mid-size medical device companies manage their quality systems in a patchwork of spreadsheets, shared drives, and email chains. This client set out to build the QMS platform that the market was missing: cloud-native, AI-augmented, covering the full compliance lifecycle, and genuinely usable by quality managers without specialist IT support. They needed a development partner who could deliver a complex multi-module SaaS product under the security and compliance requirements that medical device customers demand.
The platform needed to span the full quality lifecycle with genuine workflow automation in each module — not just document storage. Eight compliance domains, all interconnected, all regulated, all critical to get right. The AI features needed to deliver genuine value, not superficial compliance theatre.
The platform needed to span the full quality lifecycle — Documents, Training, CAPA, Risk, Supplier, Audits, Change Control, and Post-Market Surveillance — with genuine workflow automation in each, not just document storage.
FDA regulations for electronic records and signatures are specific and technically demanding. The e-signature implementation needed to satisfy audit trail, signature meaning, and record integrity requirements.
The AI risk intelligence and regulatory assistant needed to deliver genuine value — surfacing risk insights quality managers would act on, and giving regulatory guidance traceable to the correct regulatory source.
Medical device manufacturers buying a compliance platform need confidence in the security of the platform holding their quality records. ISO 27001 certification was a customer expectation, not an option.
Each module is a structured workflow system, not a document folder. Cross-module linkages mean a non-conformance in Document Management automatically creates a CAPA record, a finding in an audit triggers Change Control review, and supplier issues feed into Risk Management automatically.
Each signature carries the signer's authenticated identity, the meaning of the signature, the date and time, and an unalterable audit trail. Signed records are cryptographically locked against modification after signing.
The AI risk module analyses risk records, CAPA history, and post-market surveillance data to surface emerging risk patterns before they breach threshold. The regulatory AI assistant answers questions about FDA, MDR, and ISO 13485 requirements, grounded in the actual regulatory text with clause-level citation.
The KPI dashboard gives quality managers a real-time view of their compliance posture: open CAPAs by age and severity, document review overdue counts, training completion rates, audit findings, and supplier risk scores. APIs expose every record for ERP and EDC integrations.
Controlled document lifecycle — authoring, review, approval, versioning, and distribution with 21 CFR Part 11 signatures.
Training assignment, completion tracking, and effectiveness assessment linked to document updates.
Root cause analysis, corrective action planning, implementation tracking, and effectiveness verification.
FMEA-based risk assessment with AI risk intelligence and cross-module risk linkage.
Supplier qualification, evaluation, and risk scoring with automatic audit schedule triggers.
Internal and external audit planning, finding management, and CAPA linkage.
Change request workflow with impact assessment, approval chains, and implementation verification.
Complaint handling, vigilance reporting, and PMS data trending with AI pattern detection.
Configurable compliance KPIs with threshold alerts and trend views across all modules.
Every stage of the medical device quality lifecycle is covered in a single platform — no spreadsheet supplements, no module gaps, no manual handoffs between systems.
The entire engagement was delivered under ISO 27001 certification, giving medical device customers confidence in the security of the platform holding their quality records.
Full 21 CFR Part 11 e-signature implementation — every record signed under audit-traceable, cryptographically-protected workflows that satisfy FDA electronic records requirements.
The AI risk module surfaces emerging risk patterns before they breach threshold, moving quality management from reactive gap-closing to proactive risk prevention.
Built under ISO 27001 certification from day one. The AI layer is grounded in the actual regulatory text — every answer cites the clause it came from. Every signed record is cryptographically locked against modification after signing.
If you're building a compliance platform or quality management system for medical devices, we've delivered ISO 27001-certified QMS software with AI intelligence and 21 CFR Part 11 e-signatures. It's worth a chat.