qmsWrapper
qmswrapper.com
What it is
qmsWrapper is a cloud eQMS for medical-device, SaMD, IVD, and growing manufacturer teams. Its Foundation, Lifecycle, and Vigilance levels allow organizations to add capabilities while keeping records and processes in one system. Foundation includes controlled forms and records, documents and approvals, training, tasks, and storage. Lifecycle adds workflows for CAPA, change control, deviations, nonconformities, feedback, suppliers, and risk. Vigilance covers post-market surveillance, Technical File visibility, and audit and regulatory evidence. AI can help complete forms, search documents, assess change impact, and support traceability, while authorized users review and approve regulated decisions. Jira projects and issues can connect to qmsWrapper, appear in its Traceability Matrix, and link to risks. The maker lists electronic signatures aligned with 21 CFR Part 11 and tamper-evident audit trails. It describes the service as pre-validated SaaS, but customers remain responsible for final validation for their intended use. EU and US hosting regions are available. Foundation costs €3,499 a year; a 14-day trial is available.
Spec sheet
- What it does
- qmsWrapper is an AI-enabled eQMS for medical-device, SaMD, IVD and growing manufacturer teams.Read 2 Oct 2026 · qmswrapper.com
- Trial
- A maker blog page describes a 14-day demo trial with all functionality included; the page is dated January 29, 2026.Read 2 Oct 2026 · qmswrapper.com
- Security
- The maker says SOC 2 and ISO 27001 certifications are in progress and offers existing security controls and hosting documentation under NDA.Read 2 Oct 2026 · qmswrapper.com
- Compliance
- The maker says the platform supports work aligned with ISO 13485, ISO 14971, FDA QMSR, EU MDR and other listed regulatory frameworks.Read 2 Oct 2026 · qmswrapper.com
- Support
- The qmsWrapper documentation site provides a contact-support link for users needing help.Read 2 Oct 2026 · documentation.qmswrapper.com
- Headquarters
- Markham, Ontario, CanadaRead 28 Sep 2026 · qmswrapper.com
- Founded
- 2016Read 28 Sep 2026 · qmswrapper.com
- Maker
- The site identifies UVA Research Corp. as the company behind qmsWrapper and gives its address as Markham, Ontario, Canada.Read 2 Oct 2026 · qmswrapper.com
- AI features
- AI assists with form completion, document search, change-impact analysis and traceability, while authorized users review and approve regulated decisions.Read 2 Oct 2026 · qmswrapper.com
- Data hosting
- The maker states that EU and US hosting regions are available and customers choose where their records live.Read 2 Oct 2026 · qmswrapper.com
- Electronic records
- The site lists 21 CFR Part 11 compliant electronic signatures and complete, tamper-evident audit trails.Read 2 Oct 2026 · qmswrapper.com
- History
- The maker says qmsWrapper was first released publicly in 2016 and traces its origins to medical-technology work beginning in 1998.Read 2 Oct 2026 · qmswrapper.com
- 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.Read 2 Oct 2026 · qmswrapper.com
- Pricing limit
- The site says there are no per-seat licenses and pricing is based on company size or, for Vigilance, scope.Read 2 Oct 2026 · qmswrapper.com
- Progressive levels
- Its Foundation, Lifecycle and Vigilance levels let organizations add capabilities while keeping their records and processes in the same system.Read 2 Oct 2026 · qmswrapper.com
- Quality workflows
- Lifecycle workflows include CAPA, change control, deviations, nonconformities, feedback, supplier management and risk management.Read 2 Oct 2026 · qmswrapper.com
- 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.Read 2 Oct 2026 · qmswrapper.com
Plans and prices
Foundation €3,499 a year From €3,499/year Controlled forms and records · documents and approvals · training · tasks and storage Read 2 Oct 2026 · qmswrapper.com
Lifecycle Priced on request Priced on company size CAPA · change control · nonconformity · risk · supplier workflows Read 2 Oct 2026 · qmswrapper.com
Vigilance Priced on request Priced on scope PMS and vigilance · Technical File visibility · audit and regulatory evidence Read 2 Oct 2026 · qmswrapper.com
Strong points and limits
Strong points
- AI assists with form completion and document search.
- Jira issues can be tracked in a Traceability Matrix.
- EU and US hosting regions are available.
- Foundation includes documents, approvals, training, and tasks.
Limits
- No free plan is listed.
- Final validation remains the customer's responsibility.
- SOC 2 and ISO 27001 certifications are in progress.
Who it suits
It suits medical-device, SaMD, IVD, and growing manufacturing teams that need structured quality workflows and records. Teams can expand from Foundation toward Lifecycle or Vigilance as their needs grow.
Verdict
qmsWrapper brings quality records, workflows, and traceability into one cloud system, with capability levels for different needs. Foundation is listed at €3,499 a year, and the maker describes a 14-day trial with all functionality included.
Where Specifiction places it
- Quality Management Software#11 of 378.0