Related Products
|
||||||
About
SoftTech Health offers the most comprehensive suite of quality management software tools available in healthcare today. And since they integrate seamlessly, you’ll be able to streamline all your quality management tasks within one easy-to-use software package. Our Accreditation Manager helps you manage any upcoming inspections with tools to help you compare and copy over existing work from previous inspections. Automatically track proof of compliance and ensure nothing falls through the cracks. With every inspection, you want to: make sure that none of the requirements fall through the cracks; cut time to coordinate, track, and report on the audit; and streamline the time-consuming process of gathering your supporting evidence. The Accreditation Manager automates all these processes, improving both compliance and the bottom line at the same time.
|
About
qmsWrapper is a connected Quality Management System (eQMS) built specifically for medical device startups and SMEs. Instead of implementing a complex enterprise platform from day one, organizations can grow their QMS through three connected editions: Foundation, Lifecycle, and Vigilance.
Foundation helps companies move from paper forms, Word documents, and spreadsheets to controlled documents, workflows, training, and AI-assisted quality processes. Lifecycle adds CAPA, Quality Events, Change Control, Risk Management, Technical File management, Supplier Quality, and Smart Traceability Matrix. Vigilance extends the platform with post-market surveillance, regulatory oversight, audit readiness, and AI governance.
Built for ISO 13485, ISO 14971, FDA QMSR, FDA 21 CFR Part 11, and EU MDR, qmsWrapper helps companies scale their quality system without rebuilding or migrating to another platform.
|
|||||
Platforms Supported
Windows
Not Supported
Mac
Not Supported
Linux
Not Supported
Cloud
Supported
On-Premises
Not Supported
iPhone
Not Supported
iPad
Not Supported
Android
Not Supported
Chromebook
Not Supported
|
Platforms Supported
Windows
Supported
Mac
Supported
Linux
Supported
Cloud
Supported
On-Premises
Not Supported
iPhone
Not Supported
iPad
Not Supported
Android
Not Supported
Chromebook
Not Supported
|
|||||
Audience
Healthcare organizations looking for an inspection management software with tools for previous data and compliance track
|
Audience
Medical Device Companies, MedTech Startups, SaMD, eQMS, ISO 13485, ISO 14971, FDA QMSR, EU MDR, Quality Management, Regulatory Affairs, Quality Assurance, CAPA, Risk Management, Technical File, Traceability
|
|||||
Support
Phone Support
Supported
24/7 Live Support
Not Supported
Online
Supported
|
Support
Phone Support
Not Supported
24/7 Live Support
Not Supported
Online
Supported
|
|||||
API
Offers API
Not Supported
|
API
Offers API
Not Supported
|
|||||
Screenshots and Videos |
Screenshots and Videos |
|||||
Pricing
No information available.
Free Version
Not Supported
Free Trial
Not Supported
|
Pricing
€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
Not Supported
Free Trial
Supported
|
|||||
Reviews/
|
Reviews/
|
|||||
Pros & Cons from Real UsersPros
Cons
|
||||||
Training
Documentation
Not Supported
Webinars
Supported
Live Online
Supported
In Person
Not Supported
|
Training
Documentation
Supported
Webinars
Not Supported
Live Online
Supported
In Person
Not Supported
|
|||||
Company InformationSoftTech Health
Founded: 2003
United States
softtechhealth.com/products/
|
Company InformationqmsWrapper
Canada
www.qmswrapper.com
|
|||||
Alternatives |
Alternatives |
|||||
|
|
||||||
|
|
|
|||||
|
|
||||||
Categories |
Categories |
|||||
Accreditation Management Features
Collaboration
Supported
Compliance Management
Not Supported
Document Management
Supported
Higher Education
Not Supported
Requirements Management
Not Supported
Reviewer Portal
Not Supported
Self Assessment
Not Supported
User Access Permissions
Not Supported
Workflow Management
Not Supported
|
CAPA Features
Audit Management
Supported
CAPA Planning
Supported
Change Management
Supported
Complaint Management
Supported
Incident Management
Not Supported
Nonconformance Tracking
Supported
Quality Control
Supported
Risk Management
Supported
Root Cause Analysis
Supported
Training Management
Supported
Quality Management Features
Audit Management
Supported
Complaint Management
Supported
Compliance Management
Supported
Corrective and Preventive Actions (CAPA)
Supported
Defect Tracking
Supported
Document Control
Supported
Equipment Management
Not Supported
ISO Standards Management
Supported
Maintenance Management
Not Supported
Risk Management
Supported
Supplier Quality Control
Supported
Training Management
Supported
|
|||||
Integrations
Jira
Not Supported
|
||||||
|
|
|