Average Ratings 0 Ratings
Average Ratings 10 Ratings
Description
IMSXpress ISO 9001 serves as comprehensive software for document control and quality system management. Users can install the IMSXpress client on individual PCs or on a Windows server, which allows for distribution to users through remote desktop services as a remote application. The underlying database operates on MS SQL and can be set up on any version from MS SQL Server 2014 onward, with access to the IMSXpress application available across various network types. Options for remote access include setting up your own network, utilizing the cloud-based hosting service, or opting for an online subscription package. The system features a fully automated training module that includes self-training, integrated document training, and job descriptions, among other resources. It is designed to facilitate changes in documents, engineering, and processes, enabling users to create fillable PDF templates, populate them with data, and generate records effortlessly. Additionally, IMSXpress is useful for scheduling maintenance tasks, managing spare parts inventory, and overseeing complaints, non-conformities, risk management, and audit findings. This versatility ensures that organizations can maintain high standards in quality management while streamlining their operational processes.
Description
qmsWrapper is a connected Quality Management System (eQMS) built for medical device startups and SMEs. It helps organizations move from paper forms, Word documents, and spreadsheets to a scalable, AI-enabled QMS that grows with their business through Foundation, Lifecycle, and Vigilance. Designed for ISO 13485, ISO 14971, FDA QMSR, FDA 21 CFR Part 11, and EU MDR, qmsWrapper connects documents, quality events, risk, training, CAPA, technical documentation, and traceability in one platform.
Best For:
- Medical device and SaMD companies implementing or modernizing an ISO 13485 QMS.
- Startups and SMEs that want to grow from controlled documents to connected quality workflows without replacing their QMS.
API Access
Has API
No
API Access
Has API
No
Pricing Details
$160 per month
Free Trial
Yes
Free Version
No
Pricing Details
€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 Trial
Yes
Free Version
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
No
iPad App
No
Android App
No
Windows
Yes
Mac
No
Linux
No
Chromebook
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
No
iPad App
No
Android App
No
Windows
Yes
Mac
Yes
Linux
Yes
Chromebook
No
Customer Support
Business Hours
Yes
Live Rep (24/7)
No
Online Support
Yes
Customer Support
Business Hours
No
Live Rep (24/7)
No
Online Support
Yes
Types of Training
Training Docs
Yes
Webinars
Yes
Live Training (Online)
No
In Person
Yes
Types of Training
Training Docs
Yes
Webinars
No
Live Training (Online)
Yes
In Person
No
Vendor Details
Company Name
IMSXpress
Founded
1992
Country
Canada
Website
www.imsxp.com/00Home/IsoXpHome.aspx
Vendor Details
Company Name
qmsWrapper
Country
Canada
Website
www.qmswrapper.com
Product Features
Product Features
CAPA
Audit Management
Yes
CAPA Planning
Yes
Change Management
Yes
Complaint Management
Yes
Incident Management
No
Nonconformance Tracking
Yes
Quality Control
Yes
Risk Management
Yes
Root Cause Analysis
Yes
Training Management
Yes
Quality Management
Audit Management
Yes
Complaint Management
Yes
Compliance Management
Yes
Corrective and Preventive Actions (CAPA)
Yes
Defect Tracking
Yes
Document Control
Yes
Equipment Management
No
ISO Standards Management
Yes
Maintenance Management
No
Risk Management
Yes
Supplier Quality Control
Yes
Training Management
Yes