qmsWrapper

qmsWrapper is a quality management system (QMS) built specifically for medical device companies. It connects quality processes, design documentation, and regulatory compliance in a single platform, with a focus on automating change impact analysis and maintaining Technical File traceability. The platform is designed for MedTech startups, growing medical device teams, diagnostics and biotech companies, and Software as a Medical Device (SaMD) teams working under frameworks including FDA 21 CFR Part 11, FDA 21 CFR 820, ISO 13485:2016, EU MDR 2017/745, and UKCA.

qmsWrapper was developed in response to the common reliance on spreadsheets, email threads, and disconnected tools that make collaboration difficult and turn regulatory compliance into a largely manual process. The platform aims to bring quality management, design documentation, and product development into one connected environment where information remains traceable across the entire product lifecycle.

Who qmsWrapper Serves

• MedTech startups preparing for their first FDA QMSR, ISO 13485, or CE audit
• Medical device companies managing FDA 510(k), De Novo, MDR, or UKCA submissions
• Diagnostics and biotech companies maintaining traceability and risk management
• Software as a Medical Device (SaMD) teams navigating FDA and IVDR requirements
• ISO-certified organizations maintaining ISO 13485 or ISO 9001
• Quality and regulatory teams managing risk, CAPA, and compliance workflows

Core AI Capabilities

• Wrapper Mapper (Change Impact Analysis): Identifies exactly what needs updating across a Technical File when any quality event — change, deviation, non-conformance, or customer feedback — occurs. Described as reducing impact analysis time from hours to minutes.
• 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 support consistency and audit readiness.
• 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 other records — in a single query.

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

Compliance and Audit Readiness

• Every action within the platform is recorded, traceable, and structured for audit readiness
• Supports regulatory frameworks including ISO 13485, FDA 21 CFR 820, EU MDR 2017/745, and UKCA
• Organizes quality records so auditors can follow relationships between user needs, requirements, risks and mitigations, and design verification activities
• Designed to maintain continuous audit readiness without requiring months of preparation
• Claims to reduce manual impact analysis by over 70% compared to traditional approaches

Platform Design and Flexibility

• Workflows, modules, and traceability structures are configurable and interconnected, allowing the quality system to evolve as an organization grows
• Designed to adapt to existing team processes rather than requiring teams to conform to rigid software workflows
• All modules benefit from AI-assisted functionality and deep system integration
• Risk management integrates with design controls; forms are pre-filled with existing data; quality events remain structured and auditable

qmsWrapper continues to develop its automation and AI-assisted workflows with the stated goal of making compliance a natural part of everyday work, allowing medical device teams to focus on product quality and safety rather than system maintenance.