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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 ISOEXPRESS?

From this moment forward, you can easily acquire all the necessary documents without wasting your precious work time and at a competitive price! The subscription method is simple; just a few clicks will direct you to the purchase page, where you can enter your company's details, such as the organization name, logo, and information about the procedures approver. After filling out the forms, you can implement them according to the ISO 9001 standards displayed on your screen. With ease, you can access controlled reports and forms that proudly feature your organization's name and logo, ensuring you are thoroughly prepared for the external audit. Additionally, you can manage the preparation at your own pace, removing the need for outside help. The system is accessible year-round, allowing you to input data whenever it is most convenient for you. Don’t procrastinate until the deadline approaches! Everything required for a comprehensive quality management system is included, along with the capability to design controlled forms adorned with your company logo. This complete solution guarantees that you have all the tools necessary for the external audit and your ISO quality management system right at your fingertips. By optimizing the process, you can concentrate on what truly counts—expanding your business and enhancing its success.

Media

Media

Integrations Supported

Jira

Integrations Supported

Jira

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

$22.00/month
per month paid annually
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

ISO-EXPRESS

Date Founded

2008

Company Location

Israel

Company Website

www.iso-express.com/#/

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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