qmsWrapper - 2026 Pricing, Features, Reviews & Alternatives

1. Full visibility across the entire quality lifecycle

qmsWrapper gives you a single, real-time view of all quality and design activities. Every event, task, approval, and change is visible, traceable, and auditable from one system—eliminating blind spots and last-minute audit surprises.


2. One system for quality and design

Unlike fragmented setups, qmsWrapper connects the Quality Event System (QES) with the Design History System (DHS). Changes, CAPAs, risks, requirements, and tests are automatically linked, ensuring true end-to-end traceability across the product lifecycle.


3. Faster, more accurate event handling

Events are captured once and flow through structured workflows. Smart classification and routing reduce unnecessary escalations, prevent overuse of CAPAs, and ensure the right level of action for each issue.


4. AI assistance that reduces manual work

AI supports users during form completion, record linking, and searching across the system. This reduces repetitive data entry, improves consistency, and helps teams focus on problem-solving instead of paperwork. All decisions remain human-controlled and auditable.


5. Live, defensible traceability

The live Traceability Matrix links use cases, requirements, risks, design inputs/outputs, and tests. You can instantly see what is complete, what is missing, and how changes propagate—making your DHF defensible at any moment, not just during audits.


6. Built for audit readiness, every day

Dashboards and logs show open items, overdue actions, and approval status in real time. Audit preparation becomes a by-product of daily work, not a stressful, last-minute activity.


7. Reduced errors and improved consistency

By reusing structured data across workflows and leveraging AI assistance, qmsWrapper minimizes copy-paste errors, missing links, and inconsistent documentation—common root causes of audit findings.


8. Faster implementation for MedTech SMEs

qmsWrapper is pre-configured for ISO 13485, FDA 21 CFR Part 820 & Part 11, ISO 14971, and EU MDR. Teams can go live in weeks, not months, without large IT projects or heavy consulting dependency.


9. Scales with your organization

From early development to post-market surveillance, qmsWrapper adapts as your product portfolio and regulatory scope grow—without forcing you to migrate systems later.


10. Transparent, predictable cost

All core QMS modules are included in one price. No hidden add-ons, no feature gating, and no surprises as your quality maturity increases.