qmsWrapper ISO 13485
qmsWrapper is an AI-enabled eQMS platform for medical device, SaMD, IVD, and MedTech startups and SMEs. It delivers ISO 13485-aligned quality management with event-driven architecture, AI-powered change impact analysis, and transparent SaaS pricing starting at $6,000 per year.
- Company typePrivate
- Founded2016
- HeadquartersToronto, Canada
- Headcount11–50
- GTM typeB2B
- OfferingSoftware
What qmsWrapper ISO 13485 does
qmsWrapper is a Toronto-based software company that sells an AI-enabled electronic Quality Management System (eQMS) targeted at medical device, Software as a Medical Device (SaMD), in vitro diagnostic (IVD), and MedTech startups and small-to-medium enterprises. The platform is delivered as a single integrated SaaS application rather than a suite of separately licensed modules, and is organized into three layers — Foundation (controlled forms, taskforms, training records), Control (quality events, CAPA, change control, deviations, risk-linked workflows, and the Technical File Matrix), and Vigilance (post-market surveillance, audit evidence, and regulatory visibility across FDA QMSR, EU MDR, EU AI Act, ISO 13485, and related frameworks). Core modules span event-driven quality capture, CAPA and non-conformance management, ISO 14971 risk management, design control traceability, document control with 21 CFR Part 11 electronic signatures, complaint handling, supplier management, audit management, and training and competence tracking.
The platform's technical differentiator is operational AI layered on top of an event-driven architecture: the Wrapper-Mapper AI engine performs change impact analysis across the Technical File, a 90+ rule Change-Management AI engine identifies regulatory ripple effects, a Smart Impact Mapper executes an 11-node reasoning graph with human-in-the-loop approval, and a deterministic Regulatory Health Score provides an audit-readiness metric per device per regulator. An AI Findings Inbox with PIN-signed audit signatures and a 14-tab AI Governance Log operationalize EU AI Act Article 14 and 21 CFR Part 11 compliance. qmsWrapper integrates with Jira for engineering teams and uses Brevo for marketing automation.
Commercially, the company runs a sales-led direct go-to-market with personalized demos and inside sales motions. Pricing is publicly disclosed starting at $6,000 per year, scaling with team size, with full-access user tiers at 10, 25, and 50+ seats and all core functionality included in the base price. The company reports 135+ verified G2 customers across 25+ countries, a 4.8/5 average G2 rating, G2 High Performer recognition in 2025, and an 11-50 headcount. No external funding rounds have been disclosed in the available material, and the company is incorporated as qmsWrapper Ltd. in Ontario, Canada.
qmsWrapper ISO 13485 firmographics
Firmographics- Name
- qmsWrapper ISO 13485
- Legal name
- qmsWrapper Ltd.
- Website
- https://qmswrapper.com
- Company type
- Private
- Founded year
- 2016
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- qmsWrapper is an AI-enabled eQMS platform for medical device, SaMD, IVD, and MedTech startups and SMEs. It delivers ISO 13485-aligned quality management with event-driven architecture, AI-powered change impact analysis, and transparent SaaS pricing starting at $6,000 per year.
- Ownership category
- akta.pro rank
qmsWrapper ISO 13485 industry classification
Industry- Product category
- Medical Device Quality Management Software
- NAICS
- Computer Systems Design and Related Services (5415)
- SIC
- Services-Prepackaged Software (7372)
- akta.pro primary industry
- Quality Management Systems (QMS) & GxP Documentation (HLAGAKAD)
Keywords
Where qmsWrapper ISO 13485 is headquartered
LocationHeadquarters
- HQ city
- Toronto
- HQ country
- Canada
- HQ region
- North America
Offices1 record
Markets served
qmsWrapper ISO 13485 business model
Business model- GTM type
- B2B
- Offering type
- Software
- Cost components
- Technology or R&D, Personnel, Marketing or Sales, Infrastructure, Operations
Revenue model
- SaaS Subscription - Team Size Based: qmsWrapper is priced as a complete, fully integrated platform with plans based on team size. Starting at $6,000/year and scaling with team size. All core functionality (traceability, risk management, CAPA, AI-assisted workflows) is included with no separate modules or hidden costs. User packages are available at 10, 25, 50+ full-access user tiers.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Subscription | Annual | Base platform with all core functionality - from $6,000/year |
Go-to-market motion2 records
Distribution channels2 records
Marketing channels7 records
qmsWrapper ISO 13485 product offering
Product offeringCore offering
qmsWrapper is a cloud-based, AI-enabled electronic Quality Management System (eQMS) for medical-device, SaMD, IVD, and MedTech teams, delivered as a pre-validated SaaS platform. It consolidates quality events, CAPA, change control, risk management, design controls/traceability, document management with 21 CFR Part 11 e-signatures, supplier management, complaints, training, audit management, and post-market vigilance into a single connected system. The platform uses operational AI (Wrapper-Mapper, Change-Management AI, Smart Impact Mapper, Regulatory Health Score) to automatically maintain traceability across the Technical File and reduce manual compliance work.
Product overview
qmsWrapper is an AI-enabled eQMS (Electronic Quality Management System) for medical devices, SaMD, IVD, and MedTech teams, delivered as a single unified platform with integrated modules rather than separate products. The platform is organized in three capability layers: Foundation (controlled forms, taskforms, training records), Control (regulated quality workflows including CAPA, change, N-C, deviation, feedback, suppliers, risk, and Technical File/Traceability Matrix), and Vigilance (post-market oversight including PMS, audit evidence, FDA QMSR and EU MDR visibility). Core modules include Event-Driven QMS, CAPA & Non-Conformance, Risk Management (ISO 14971), Design Control Traceability Matrix, Document Management with e-Signatures, Customer Complaints, Supplier Management, Project & QMS Management, Change & Deviation Management, Audit Management, Training & Competence, Form Editor, Process Workflow Editor, and Team Messaging. AI-powered features include Wrapper-Mapper (AI change impact analysis), Change-Management AI (90+ rules engine), Smart Impact Mapper, Regulatory Health Score, AI Findings Inbox, AI-Powered Search, Smart Form Assistant, and AI Help Assistant. The platform integrates with Jira for engineering workflow linking. All AI capabilities operate under Human-in-the-Loop (HITL) principles with PIN-signed approval for regulatory compliance.
Differentiator
Problem solved
Functional benefit
Products and services
- qmsWrapper eQMS Platform Cloud-based, AI-enabled electronic Quality Management System (eQMS) for medical-device, SaMD, IVD, and MedTech SMEs, delivered as a pre-validated SaaS platform. Consolidates quality events, CAPA, change control, risk management (ISO 14971), design controls and traceability matrix, document management with 21 CFR Part 11 e-signatures, supplier management, complaints, training, audit management, and post-market vigilance (PMS, EUDAMED, EU AI Act) into a single connected, HITL-controlled AI platform. Sold as an annual subscription starting at $6,000/year scaling with team size (10, 25, 50+ full-access user tiers).
- Pre-Validated SaaS Deployment Pre-configured, validated SaaS deployment of the qmsWrapper platform tailored for regulated environments. Ships with ISO 13485-aligned structure and built-in workflows to enable rapid validation and onboarding for medical device customers.
Quantifiable outcome
- Traceability maintenance reduced by over 80%
- +3 more outcomes
Companies that use qmsWrapper ISO 13485
Customer profileNamed customers4 records
Segments5 records
Ideal customer profiles3 records
qmsWrapper ISO 13485 technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Integration2 records
AI capability9 records
Feature12 records
qmsWrapper ISO 13485 partnerships and signals
Strategic signalPartnerships
Two partnerships are on record, tiered core.
- JiracoreqmsWrapper integrates with Jira for engineering teams. Engineering teams already in Jira can keep their issue tracker in place and link quality events to product work. This integration allows quality events to be connected to product development tasks while maintaining existing engineering workflows.
- Brevo (Sendinblue)coreBrevo is used as qmsWrapper's email marketing and CRM platform. Customer data including name, email address, and whitepaper download history is shared with Brevo to manage email communications and track engagement. Brevo is GDPR-compliant with servers located in the European Union.
Scale indicators3 records
Recent moves5 records
Expansion highlights5 records
qmsWrapper ISO 13485 competitors and assessment
Company assessmentDirect peers
- Greenlight Guru: Greenlight Guru is an eQMS platform purpose-built for medical device companies, offering ISO 13485, FDA, and EU MDR compliance. It is the most direct competitor to qmsWrapper, explicitly named in qmsWrapper's comparison pages and targeting the same MedTech startup-to-enterprise segment.
- Qualio: Qualio is a cloud-based eQMS for life sciences companies spanning medical devices, pharma, and biotech, with ISO 13485, FDA 21 CFR Part 11, and EU compliance. Like qmsWrapper, it targets growing life-sciences teams and is named by qmsWrapper as a primary competitor.
- Dot Compliance: Dot Compliance provides a Salesforce-native QMS for life sciences including medical devices, pharma, and biotech, covering CAPA, change control, training, and audits. It competes directly with qmsWrapper in the regulated eQMS category but with a CRM-first delivery model.
- SimplerQMS: SimplerQMS is a cloud eQMS platform for medical device and life sciences companies targeting ISO 13485, FDA, and EU MDR compliance. It is a closer-sized direct competitor to qmsWrapper, also focused on SMEs in the medical-device vertical.
- ComplianceQuest: ComplianceQuest is a Salesforce-native EQMS platform covering quality, safety, and compliance for life sciences and manufacturing. It competes in the same eQMS category as qmsWrapper, serving regulated industries with document control, CAPA, and risk management.
Broad incumbents
- MasterControl: MasterControl is a long-established eQMS and quality management platform serving life sciences and broader regulated industries with document control, CAPA, training, and audit management. It is a broader incumbent with deeper enterprise penetration than qmsWrapper but less AI-native architecture.
- Sparta Systems (TrackWise, a Honeywell company): Sparta Systems' TrackWise QMS, now part of Honeywell, is an enterprise quality management platform used widely across pharma, medical devices, and other regulated industries. It is a much larger, established incumbent compared with qmsWrapper, focused on enterprise-scale deployments.
- Veeva Systems: Veeva Systems is a major life-sciences cloud platform with Veeva Vault Quality offering document, training, and QMS capabilities for pharma and medical-device companies. It is a broader incumbent with deep regulatory content and a large enterprise customer base.
- ETQ (Hexagon): ETQ Reliance, part of Hexagon, is a quality management system serving manufacturing, life sciences, food and beverage, and other regulated industries. It competes with qmsWrapper at the broader eQMS level, with much larger scale and broader vertical coverage.
Emerging players
- AssurX: AssurX provides quality management and regulatory compliance software for life sciences and other regulated manufacturers, covering document control, CAPA, and audit management. It is a focused niche player overlapping with qmsWrapper in regulated eQMS but with broader vertical coverage.
Market position
Strengths4 records
Weaknesses5 records
Competitive moat4 records
Key risks6 records
Key highlights7 records
Customer concentration
qmsWrapper ISO 13485 social profiles
Digital presenceqmsWrapper ISO 13485 compliance and trust
Trust signalCompliance6 records
qmsWrapper ISO 13485 financial estimates
Financial estimateRevenue estimate
Valuation estimate
qmsWrapper ISO 13485 leadership team
Management profileNumber of profiles
qmsWrapper ISO 13485 funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
qmsWrapper ISO 13485 M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about qmsWrapper ISO 13485
What does qmsWrapper ISO 13485 do?
qmsWrapper is a cloud-based, AI-enabled electronic Quality Management System (eQMS) for medical-device, SaMD, IVD, and MedTech teams, delivered as a pre-validated SaaS platform. It consolidates quality events, CAPA, change control, risk management, design controls/traceability, document management with 21 CFR Part 11 e-signatures, supplier management, complaints, training, audit management, and post-market vigilance into a single connected system. The platform uses operational AI (Wrapper-Mapper, Change-Management AI, Smart Impact Mapper, Regulatory Health Score) to automatically maintain traceability across the Technical File and reduce manual compliance work.
Is qmsWrapper ISO 13485 a public or private company?
qmsWrapper ISO 13485 is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was qmsWrapper ISO 13485 founded?
qmsWrapper ISO 13485 was founded in 2016. It employs 11 to 50 people.
Where is qmsWrapper ISO 13485 based?
qmsWrapper ISO 13485 is headquartered in Toronto, Canada, in the North America region.
How does qmsWrapper ISO 13485 make money?
One revenue line is on record: saaS Subscription - Team Size Based.
Who are qmsWrapper ISO 13485's main competitors?
Direct peers on record are Greenlight Guru, Qualio, Dot Compliance, SimplerQMS and ComplianceQuest. Broad incumbents are MasterControl, Sparta Systems (TrackWise, a Honeywell company), Veeva Systems and ETQ (Hexagon). AssurX is listed as an emerging player.
Does qmsWrapper ISO 13485 have an API?
No public API is recorded for qmsWrapper ISO 13485.
What industry is qmsWrapper ISO 13485 in?
qmsWrapper ISO 13485's product category is Medical Device Quality Management Software. Its primary akta.pro industry code is HLAGAKAD, Quality Management Systems (QMS) & GxP Documentation. Its NAICS code is 5415 and its SIC code is 7372.