qmsWrapper

qmsWrapper is an AI-based quality management system (QMS) built for medical device companies. It automatically maps quality events — including changes, deviations, non-conformances, and customer feedback — to the relevant sections of a Technical File, reducing the manual effort required for impact analysis and audit preparation. The platform is designed to support compliance with FDA, ISO 13485, EU MDR, and UKCA requirements.

qmsWrapper is intended for MedTech startups preparing for their first regulatory audit, medical device companies managing 510(k), De Novo, MDR, or UKCA submissions, diagnostics and biotech companies, Software as a Medical Device (SaMD) teams, ISO-certified organizations, and quality and regulatory affairs teams managing risk, CAPA, and compliance workflows.

Core AI Capabilities

• Traceability Matrix Automation: Automatically creates and maintains traceability across requirements, risks, and verification activities.
• AI Risk Assistant: Builds and updates risk analysis based on real system data and changes.
• AI Form Completion: Pre-fills quality forms using existing data to improve consistency and speed.
• AI Event Intelligence: Captures and manages deviations, CAPAs, and quality events with full context.
• AI Knowledge Search (CORE): Enables search across the entire QMS — documents, risks, events, and records — in a single query.
• Wrapper Mapper (Change Impact Analysis): Identifies exactly which elements of the Technical File are affected when a change occurs.

Platform Modules

• Document Management and Electronic Signatures
• Design Controls
• Traceability Matrix
• Risk Management (ISO 14971)
• CAPA and Nonconformities
• Training Management
• Supplier Management
• Customer Complaints
• Change and Deviation Management
• Audit Management

Audit Readiness and Traceability

• All records include version history, electronic signatures, and full audit trails.
• The system organises relationships between user needs, requirements, risks and mitigations, design inputs and outputs, verification and validation, and CAPAs and quality events.
• Documentation, processes, risks, and verification activities remain continuously connected and audit-ready without requiring manual maintenance.
• Audits can be conducted as structured system reviews rather than requiring teams to piece together evidence from multiple files.

Regulatory Compliance Coverage

• FDA 21 CFR Part 820 (QMSR)
• FDA 21 CFR Part 11 (electronic records and signatures)
• ISO 13485 and ISO 9001
• ISO 14971 (risk management)
• EU MDR 2017/745 and IVDR
• UKCA
• 510(k) submission support
• GDPR and HIPAA

AI Governance and Human Oversight

• AI assists with traceability updates, risk analysis, and form completion, but all outputs remain reviewable and editable by the team.
• Approvals and final decisions remain with human users.
• Every AI-assisted action is recorded with a complete audit trail.

Flexibility and Configuration

• Workflows, modules, and traceability structures are configurable to match existing organisational processes.
• Teams can configure workflows and approvals, build custom forms and modules, and evolve processes as the organisation grows.
• Existing documentation and processes can be migrated into the platform and connected within the integrated structure.
• The platform is designed to scale with growing teams, increasing document volume, and expanding regulatory requirements.

Reported Outcomes

• Manual traceability maintenance reduced by over 80%.
• Impact analysis time reduced from hours to minutes.
• Manual impact analysis reduced by over 70%.
• Audit preparation time significantly reduced.
• Risk management integrated with design controls rather than maintained separately.

qmsWrapper is delivered with an ISO 13485-aligned structure and prebuilt workflows, with most organisations operational within approximately one week. Pricing is based on team size and includes all core functionality — traceability, risk management, CAPA, and AI-assisted workflows — with no separate module fees. The platform supports GDPR and HIPAA in addition to medical device regulatory frameworks.