qmsWrapper's pages describe a quality system built around quality events, which are triaged by risk into nonconformance or CAPA records and linked to change, deviation, complaint and risk work. It is sold in three levels: Foundation (forms, documents, e-signatures, training), Lifecycle (CAPA, change, risk, supplier) and Vigilance (technical file, post-market surveillance, audit evidence). The technical overview also lists an audit trail per entity and an AI findings inbox with human approval.
Built from vendor sources checked ; AI-assisted drafting. Documentation review, not a hands-on test. How pages are made
Small and mid-sized medical device companies replacing paper or spreadsheet records and wanting linked design, risk, CAPA and post-market records. An API, single sign-on and offline use are not described on the vendor pages, and the pages give differing statements on SOC 2 and ISO 27001, so neither is claimed. Prices for Lifecycle and Vigilance are not shown. The standards wording describes alignment, not software certification.
Watch for: An API, offline use and SOC 2 / ISO 27001 status are unclear.
Published price: From €3,499 per year for Level 1 - Foundation. Sources checked .
Vendor visuals—not a QHSEtech hands-on test.
qmsWrapper is an electronic quality management system for medical device, SaMD and in-vitro diagnostic teams. The site footer says it is a division of UVA Research Corp. of Markham, Ontario, Canada, and the vendor states a figure of 500+ medtech teams. This profile covers quality management only, not EHS or occupational safety. ISO 13485, FDA 21 CFR Part 820, 21 CFR Part 11 and EU MDR are named as frameworks the workflows align with; no certificate for the software is named. Document control, e-signatures, training, CAPA, nonconformance, change, complaints, risk, design traceability, supplier, audit and post-market records for medical device quality systems.
| Capability | Evidence | Scope and source |
|---|---|---|
| Quality events, CAPA and nonconformance | Documented by vendor | The CAPA page describes events classified by risk and escalated only when justified, nonconformance as its own record, a lighter log and an eight-stage lifecycle with independent QA sign-off. qmsWrapper CAPA and nonconformance page, checked 2 October 2026qmsWrapper technical overview, checked 2 October 2026 |
| Document control and electronic signatures | Documented by vendor | The pages describe versioned documents, approval chains and signatures linked to a document version, user, role and time, described as aligned with, or compliant with, 21 CFR Part 11. No certification is named. qmsWrapper document control and e-signatures page, checked 2 October 2026qmsWrapper technical overview, checked 2 October 2026 |
| ISO 14971 risk management and hazard logs | Documented by vendor | The risk page describes hazard logs, risk evaluation, controls and residual risk linked to requirements and design elements, with events triggering re-evaluation. qmsWrapper ISO 14971 risk management page, checked 2 October 2026qmsWrapper home page, checked 2 October 2026 |
| Design control and traceability matrix | Documented by vendor | The pages describe linked user needs, requirements, risks, inputs, outputs, validation and verification records, and a design history file and technical file structure. qmsWrapper design control traceability page, checked 2 October 2026qmsWrapper technical overview, checked 2 October 2026 |
| Audit management | Documented by vendor | The audit page describes planning and running internal, external and supplier audits with checklists, and converting findings into events, CAPA and actions. qmsWrapper audit module page, checked 2 October 2026 |
| Post-market vigilance and EUDAMED records | Depends on scope | The technical overview lists a Vigilance Log and an EUDAMED Compliance Log, and the home page places PMS and vigilance in the Vigilance level. Detail and direct submission to a regulator are not described. qmsWrapper technical overview, checked 2 October 2026qmsWrapper home page, checked 2 October 2026 |
| Complaints, supplier and training records | Depends on scope | The home page names complaints, supplier management and training as modules, and the technical overview lists a supplier log and training. Depth is not shown, so check it in a demo. qmsWrapper home page, checked 2 October 2026qmsWrapper technical overview, checked 2 October 2026 |
| Configurable forms and workflows | Depends on scope | The home page names a Form Editor and a Process Workflow Editor, and the technical overview an approval engine. Configuration depth is not shown. qmsWrapper home page, checked 2 October 2026qmsWrapper technical overview, checked 2 October 2026 |
| AI assistance with human approval | Documented by vendor | The pages describe AI form assistance, knowledge search, drafting suggestions and a findings inbox, with regulated decisions and approvals left to authorised users. qmsWrapper home page, checked 2 October 2026qmsWrapper CAPA and nonconformance page, checked 2 October 2026qmsWrapper technical overview, checked 2 October 2026 |
| Validation documentation and security | Depends on scope | The validation page describes vendor validation documents per release, with customer validation still needed. The home page lists EU and US hosting regions. The pages give differing statements on SOC 2 and ISO 27001, so neither is claimed. qmsWrapper pre-validated SaaS page, checked 2 October 2026qmsWrapper home page, checked 2 October 2026qmsWrapper technical overview, checked 2 October 2026 |
| Integrations and API | Not verified | An API and system integrations are not described on the vendor pages; the home page mentions only MCP access for AI agents, varying by level. A third-party listing names Jira, unconfirmed by the vendor. |
Three levels; Level 1 - Foundation shown per year, Lifecycle and Vigilance priced on request
The subscription terms page, the home page and the demo page show one amount: pricing starts at €3,499 per year for Level 1 - Foundation. Lifecycle is described as priced on company size and Vigilance as priced on scope, with no amount shown for either. The home page says there are no per-seat licences and that pricing follows company size, not user count. A trial is not described on the vendor pages, though a third-party listing mentions one.
Separate pricing recheck date not recorded. Confirm current pricing with the vendor.
Offline use and a mobile app are not described on the reviewed pages.
The pages name these standards as frameworks the workflows align with. They do not present the software as certified to them.
The pages give differing statements on both, so neither is claimed here. Ask the vendor for reports and their scope.
Drawn from the profiles behind the Alternatives list above: most category tags shared with qmsWrapper first, then the closest overlap in documented capability names, then A to Z. Ratings, search demand and sponsorship are not used; rows are shown A to Z.
Shared category tags: 5 (Quality Management, CAPA Management, others).
Differs: trial free trial documented (this profile: not established).
Same: scope, offline and price.
Shared category tags: 4 (Quality Management, CAPA Management, others).
Differs: trial on request (this profile: not established).
Same: scope, offline and price.
Shared category tags: 5 (Quality Management, CAPA Management, others).
Differs: trial on request (this profile: not established).
Same: scope, offline and price.
Also recorded as QMSWrapper. Older entries under a previous name may describe a different release or owner.
Star ratings and review counts from the old catalog are not shown: no source for them was recorded.
