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What is qmsWrapper?

qmsWrapper is a connected Quality Management System (eQMS) designed specifically for medical device startups and SMEs. Instead of implementing a complex enterprise platform from day one, companies can start with Foundation and expand to Lifecycle and Vigilance as their quality system matures. Built for ISO 13485, ISO 14971, FDA QMSR, FDA 21 CFR Part 11, and EU MDR, qmsWrapper connects document control, training, CAPA, quality events, risk management, technical documentation, supplier quality, and traceability in one platform. AI assists users with quality processes while every action remains human-controlled and fully auditable. Start where the need is greatest. Keep everything you build. Grow your QMS without rebuilding or migrating to another system.

What is Q-Med Database?

The Q-Med Database is an excellent resource for small enterprises aiming to achieve ISO 13485 compliance. This comprehensive database facilitates the effective management of various aspects, including corrective and preventive actions, nonconformances, internal audit schedules and findings, safety improvements, supplier corrective actions, and ongoing improvement projects. In addition, it allows for the compilation and analysis of customer survey results, as well as documentation of Quality Management System (QMS) review meetings and their outcomes. Furthermore, it is compliant with CFR21 Part 11, ensuring regulatory adherence, and offers both cloud-based and locally installed options to suit different operational needs. With its user-friendly interface, the Q-Med Database empowers small businesses to streamline their compliance efforts and enhance overall quality management.

Media

Media

Integrations Supported

Jira
Sunday Business Systems

Integrations Supported

Jira
Sunday Business Systems

API Availability

Has API

API Availability

Has API

Pricing Information

€3,499
Foundation starts at €3,499 per year with unlimited users. Lifecycle and Vigilance pricing is available on request. All editions are designed to grow with your quality management needs without requiring migration to a new platform.
Free Version
Free Trial Offered?

Pricing Information

$1900.00/one-time
Licenses based on concurrent users
Free Version
Free Trial Offered?

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Company Facts

Organization Name

qmsWrapper

Company Location

Canada

Company Website

www.qmswrapper.com

Company Facts

Organization Name

Sunday Business Systems

Date Founded

2004

Company Location

United States

Company Website

sundaybizsys.com/q-med-database/

Categories and Features

CAPA

Audit Management
CAPA Planning
Change Management
Complaint Management
Incident Management
Nonconformance Tracking
Quality Control
Risk Management
Root Cause Analysis
Training Management

Quality Management

Audit Management
Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Defect Tracking
Document Control
Equipment Management
ISO Standards Management
Maintenance Management
Risk Management
Supplier Quality Control
Training Management

Categories and Features

Quality Management

Audit Management
Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Defect Tracking
Document Control
Equipment Management
ISO Standards Management
Maintenance Management
Risk Management
Supplier Quality Control
Training Management

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