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qmsWrapper
What qmsWrapper is
qmsWrapper is a cloud-based, AI-enabled electronic quality management system for medical-device, software as a medical device (SaMD), in-vitro diagnostic (IVD), and growing manufacturer teams. Its Foundation, Lifecycle, and Vigilance levels let organizations add capabilities while keeping records and processes in one system. Foundation includes controlled forms and records, documents and approvals, training, tasks, and storage. Lifecycle workflows cover corrective and preventive action (CAPA), change control, deviations, nonconformities, feedback, supplier management, and risk management. Vigilance covers post-market surveillance and vigilance, Technical File visibility, and audit and regulatory evidence.
AI assists with completing forms, finding documents, assessing change impact, and traceability. Authorized users review and approve regulated decisions. Jira projects and issues can be connected, tracked in qmsWrapper’s Traceability Matrix, and linked to risks. The platform lists electronic signatures aligned with 21 CFR Part 11 and tamper-evident audit trails. Its maker describes the service as pre-validated SaaS and says vendor validation documentation is available; customers remain responsible for final validation for their intended use. EU and US hosting regions are available, with customers choosing where records live. Foundation starts at €3,499/year, and a 14-day demo trial includes all functionality. It runs on Linux, Windows, and the web.
Who it suits
qmsWrapper suits medical-device, SaMD, IVD, and growing manufacturer teams that need controlled quality records and workflows. Organizations can begin with Foundation and add Lifecycle or Vigilance capabilities, while keeping processes and records together.
What it does well
- AI assists with form completion, document search, and traceability.
- Lifecycle includes CAPA, change control, and risk workflows.
- Jira issues can be tracked and linked to risks.
- EU and US hosting regions are available.
- The 14-day demo trial includes all functionality.
What to know first
- There is no free plan.
- Foundation starts at €3,499/year.
- Lifecycle pricing depends on company size.
- Customers remain responsible for final validation for their intended use.
Limits
Foundation starts at €3,499/year and covers controlled forms and records, documents and approvals, training, tasks, and storage. Lifecycle pricing is based on company size, and Vigilance pricing is based on scope.
Plans
| Plan | Billed and limits | Price |
|---|---|---|
| Foundation | From €3,499/year · Controlled forms and records · documents and approvals · training · tasks and storage | €3,499 a year |
| Lifecycle | Priced on company size · CAPA · change control · nonconformity · risk · supplier workflows | On request |
| Vigilance | Priced on scope · PMS and vigilance · Technical File visibility · audit and regulatory evidence | On request |
As qmswrapper.com lists them, read 2 Oct 2026. The maker's own page has the final word.
Getting started
- Visit qmswrapper.com.
- Start the 14-day demo trial with all functionality included.
- Choose Foundation, Lifecycle, or Vigilance according to the capabilities needed.
- Use the cloud service on the web, Linux, or Windows.
- Choose an EU or US hosting region for your records.
Verdict
Choose qmsWrapper if your manufacturer team needs quality workflows, records, and approvals in one system, with the option to add Lifecycle or Vigilance capabilities. Look elsewhere if you need a free plan or want the vendor to take responsibility for final validation.
Questions
How much does qmsWrapper cost?
Foundation starts at €3,499/year. Lifecycle is priced based on company size, while Vigilance is priced based on scope.
Does qmsWrapper have a free plan or trial?
There is no free plan. A 14-day demo trial includes all functionality.
Which platforms does qmsWrapper support?
The listed platforms are Linux, web, and Windows. Deployment is cloud.
Can qmsWrapper connect to Jira?
Yes. Jira projects and issues can be connected, tracked in the Traceability Matrix, and linked to risks.
Who makes qmsWrapper?
UVA Research Corp. is identified as the company behind qmsWrapper, with an address in Markham, Ontario, Canada.
Who is responsible for final validation?
The maker describes qmsWrapper as pre-validated SaaS and says vendor validation documentation is available. Customers remain responsible for final validation for their intended use.
Facts from qmsWrapper's own pages
- AI features
- AI assists with form completion, document search, change-impact analysis and traceability, while authorized users review and approve regulated decisions. · qmswrapper.com, 2 Oct 2026
- Compliance
- The maker says the platform supports work aligned with ISO 13485, ISO 14971, FDA QMSR, EU MDR and other listed regulatory frameworks. · qmswrapper.com, 2 Oct 2026
- Data hosting
- The maker states that EU and US hosting regions are available and customers choose where their records live. · qmswrapper.com, 2 Oct 2026
- Electronic records
- The site lists 21 CFR Part 11 compliant electronic signatures and complete, tamper-evident audit trails. · qmswrapper.com, 2 Oct 2026
- Founded
- 2016 · qmswrapper.com, 28 Sept 2026
- Headquarters
- Markham, Ontario, Canada · qmswrapper.com, 28 Sept 2026
- History
- The maker says qmsWrapper was first released publicly in 2016 and traces its origins to medical-technology work beginning in 1998. · qmswrapper.com, 2 Oct 2026
- Jira integration
- The maker says Jira projects and issues can be connected to qmsWrapper, with issues tracked in its Traceability Matrix and linked to risks. · qmswrapper.com, 2 Oct 2026
- Maker
- The site identifies UVA Research Corp. as the company behind qmsWrapper and gives its address as Markham, Ontario, Canada. · qmswrapper.com, 2 Oct 2026
- Pricing limit
- The site says there are no per-seat licenses and pricing is based on company size or, for Vigilance, scope. · qmswrapper.com, 2 Oct 2026
- Progressive levels
- Its Foundation, Lifecycle and Vigilance levels let organizations add capabilities while keeping their records and processes in the same system. · qmswrapper.com, 2 Oct 2026
- Quality workflows
- Lifecycle workflows include CAPA, change control, deviations, nonconformities, feedback, supplier management and risk management. · qmswrapper.com, 2 Oct 2026
- Security
- The maker says SOC 2 and ISO 27001 certifications are in progress and offers existing security controls and hosting documentation under NDA. · qmswrapper.com, 2 Oct 2026
- Support
- The qmsWrapper documentation site provides a contact-support link for users needing help. · documentation.qmswrapper.com, 2 Oct 2026
- Trial
- A maker blog page describes a 14-day demo trial with all functionality included; the page is dated January 29, 2026. · qmswrapper.com, 2 Oct 2026
- Validation
- qmsWrapper describes itself as pre-validated SaaS and says vendor validation documentation is available, while customers remain responsible for final validation for their intended use. · qmswrapper.com, 2 Oct 2026
- What it does
- qmsWrapper is an AI-enabled eQMS for medical-device, SaMD, IVD and growing manufacturer teams. · qmswrapper.com, 2 Oct 2026
Where qmsWrapper stands on Freedom251
- Quality Management Software#13 of 37