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On the recordRead 2 Oct 202617 facts
qmsWrapper
Markham, Ontario, Canada
Plans and prices
Foundation
€3,499a year
Controlled forms and records · documents and approvals · training · tasks and storage
Read 2 Oct 2026 · qmswrapper.com
Lifecycle
Priced on request
CAPA · change control · nonconformity · risk
Read 2 Oct 2026 · qmswrapper.com
Vigilance
Priced on request
PMS and vigilance · Technical File visibility · audit and regulatory evidence
Read 2 Oct 2026 · qmswrapper.com
On the record
- AI features
- AI assists with form completion, document search, change-impact analysis and traceability, while authorized users review and approve regulated decisions.qmswrapper.com · read 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 · read 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 · read 2 Oct 2026
- Electronic records
- The site lists 21 CFR Part 11 compliant electronic signatures and complete, tamper-evident audit trails.qmswrapper.com · read 2 Oct 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 · read 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 · read 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 · read 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 · read 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 · read 2 Oct 2026
- Quality workflows
- Lifecycle workflows include CAPA, change control, deviations, nonconformities, feedback, supplier management and risk management.qmswrapper.com · read 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 · read 2 Oct 2026
- Support
- The qmsWrapper documentation site provides a contact-support link for users needing help.documentation.qmswrapper.com · read 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 · read 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 · read 2 Oct 2026
- What it does
- qmsWrapper is an AI-enabled eQMS for medical-device, SaMD, IVD and growing manufacturer teams.qmswrapper.com · read 2 Oct 2026