Product – qmsWrapper

Core QMS Modules

Event-Driven QMS for Medical Device Quality Management

The event-driven QMS architecture is the foundation of the broader qmsWrapper product platform for managing medical device quality and compliance. qmsWrapper is built around an event-driven QMS, implemented through a Quality Event System (QES), where every deviation, complaint, change, or audit finding starts as a structured form and becomes a traceable record. Events are logged, triaged, and linked to the right processes (tasks, CAPA, Change Control), so nothing falls through the cracks. The result is a live QMS where your logs, dashboards, and reports always reflect what’s really happening on the floor and in the field.

Project & QMS Mgmt

Project Management and Quality Management live in the same workspace, so every task, document, and event stays connected to the right product and process. Pre-defined and configurable workflows help your team run projects that are automatically aligned with ISO 13485 and FDA QSR requirements. Instead of adding bureaucracy, qmsWrapper weaves QMS checkpoints into daily work, so compliance becomes a natural outcome of how projects are executed.

CAPA & Non-Conformance

Non-conformities and incidents are captured through simple forms, routed through investigation, root-cause analysis, and corrective/preventive actions in a structured, closed-loop process. Smart triage prevents over-escalation, so only the right issues become full CAPAs while minor cases are handled as simpler actions. Linked logs show the full history from issue to fix and follow-up, giving auditors and managers clear evidence that problems are understood and controlled. These closed-loop CAPA controls support compliance with the regulatory frameworks described in our Regulatory & Quality Standards approach.

Change and Deviation Mgmt

Change Requests and Deviations are managed through guided workflows that capture impact, approvals, and implementation steps in one place. Whether it’s a temporary concession or a permanent design or process change, qmsWrapper links each decision back to the affected requirements, risks, and documents. This ensures that nothing changes “off the books” and every deviation or change leaves a clean, auditable trail across your QMS and design history.

Risk Mgmt (ISO 14971) & Hazard Logs

The Risk Management module follows ISO 14971 and keeps all hazards, hazardous situations, and risk evaluations in structured Hazard Logs. Risks are connected to requirements, design elements, events, and CAPA actions, so every new complaint or failure can trigger a re-evaluation. Dashboards and reports show your current risk profile at a glance, helping you maintain a living, traceable Risk Management File instead of a static document that’s updated only at audit time. Risk records are continuously synchronized with Design Control & Traceability to ensure complete lifecycle consistency.

Design Control & Traceability Matrix

qmsWrapper’s Traceability Matrix acts as the backbone of your Design History File (DHF) or Technical File, linking user needs, use cases, requirements, design inputs/outputs, tests, risks, and changes in one live view. When an event from the QES impacts design, the connected items in the matrix are updated, keeping the story of your device consistent and complete. This makes 510(k), CE Mark, and MDR submissions faster, with less manual reconstruction and fewer traceability gaps. This structured DHF and Technical File directly support preparation for internal and external reviews within the Audit Module.

Document Mgmt & E-Signatures

All QMS and design documents are stored in a central, version-controlled repository with full audit trail, metadata, and access control. Review and approval workflows use compliant electronic signatures, supporting FDA 21 CFR Part 11 requirements while simplifying day-to-day work. Teams always know which version is current, who approved it, and how it’s linked to procedures, risks, and events—so you can walk into any audit confident in your documentation.

Customer Complaints Mgmt

Complaints and feedback from the field are captured in structured forms that feed directly into your QMS and Risk Management processes. Each complaint can trigger investigations, CAPA, or Change Control, with all related records linked and visible in the Event Log. This turns post-market surveillance into a closed loop: issues are logged, assessed, acted on, and traced all the way back to requirements, design, and risk files.

Audit Module

Plan, schedule, and execute internal, external, and supplier audits within qmsWrapper, using checklists and forms aligned with your procedures and regulatory expectations. Findings, observations, and non-conformities are instantly converted into events or CAPA records, ensuring audit outputs always drive follow-up action. The full audit trail—scope, evidence, conclusions, and actions—is stored and searchable, helping you prepare for regulators and notified bodies with minimal extra effort.

Supplier Mgmt and Manufacturing

Supplier records, qualifications, and performance data are managed in one place, tightly linked to NCRs, SCARs, and audit findings. Issues in manufacturing or incoming inspection can be traced back to specific suppliers, lots, or components, and corrective actions are documented in the same QMS. This gives you clear visibility into supplier risk and manufacturing quality, supporting MDR, ISO 13485, and FDA expectations for controlled outsourced processes.

Productivity Tools

Training & Competence

Assign, track, and document training directly within qmsWrapper, linking each record to roles, procedures, and events. Training completion and competence are fully traceable: you can see who was trained on which SOP, when, and in response to which change, deviation, or CAPA. This makes it easy to prove competency to auditors and to identify training gaps that may contribute to recurring issues.

Form Editor

The Form Editor lets you build custom, web-based forms that match your processes—no coding required. From deviations and CAPAs to training records and design inputs, every form can trigger workflows, tasks, and notifications so your SOPs are enforced automatically. Structured data replaces messy spreadsheets and emails, making your logs, dashboards, and reports cleaner and more audit-ready.

Process Workflow Editor

With the Workflow Editor, you can map your SOPs into step-by-step digital workflows that enforce the right sequence of actions, approvals, and reviews. Each workflow can be tailored to your regulatory pathway and device risk class, while still staying easy for front-line users to follow. As regulations or procedures change, you update the workflow once—and every new record follows the improved process.

Team Messaging & Meetings

Built-in chat and meeting tools keep collaboration inside your QMS instead of scattered across external apps. Discussions can be saved as meeting records with agenda, minutes, decisions, and follow-up tasks, all linked to the relevant project, event, or document. This turns everyday communication into structured, auditable evidence that supports your design reviews, CAPA boards, and management reviews.

Integration with Jira

For development teams using Jira, qmsWrapper brings issues and sprints into the same environment as your QMS and Traceability Matrix. Requirements, risks, and tests in qmsWrapper can be linked to Jira issues, so each bug, change, or user story is automatically part of your DHF/Technical File. This creates a single source of truth where engineering and regulatory teams see the same data, without double entry or manual syncing.

AI-Powered Features

AI Help Assistant

The AI Help Assistant guides users as they work, answering “how do I…?” questions in context and pointing to the right forms, procedures, or records. It helps new team members onboard faster and reduces dependency on QA/RA for everyday how-to support. Over time, it becomes a knowledge layer on top of your QMS, making complex processes feel simpler and more approachable.

Smart Form Assistant

The Smart Form Assistant uses AI to pre-fill fields, suggest links to related records (risks, documents, past events), and highlight missing or inconsistent information before a form is submitted. It turns repetitive data entry into a guided experience that’s faster and less error-prone. This not only saves time for engineers and quality staff, but also improves the quality of data flowing into your logs, reports, and submissions.

Regulatory Standards

Regulatory & Quality Standards

qmsWrapper is designed for regulated MedTech environments, with workflows and templates aligned to ISO 13485, ISO 14971, ISO 9001, FDA 21 CFR 820 and 21 CFR 11, EU MDR/IVDR expectations, and 510(k)-ready traceability structures. Instead of starting from a blank system, you begin with pre-configured building blocks that reflect how auditors and notified bodies expect your QMS and DHF/Technical File to be organized. This helps you implement best practice faster, reduce compliance risk, and stay ready for evolving regulatory requirements.