SoftComply eQMS (MedTech QMS Starter Pack)
Free app
OVERALL RATINGS
INSTALLS
400
SUPPORT
- Partner Supported
TRUST SIGNALS
Key highlights of the appContact SoftComply to get FDA, MDR, TGA & Canada MDR Compliant Quality System Docs for ISO13485, IEC62304, ISO14971, 21 CFR 820
Extend the Content into a full Cloud eQMS Solution
The SoftComply eQMS can easily be extended to an FDA and MDR compliant Cloud eQMS Solution based on existing Confluence apps and SoftComply's services.
A Fully Customizable Quality Management System
Limited trial view of a Quality Management System for Medical Devices. Based on ISO 13485, IEC 62304 & 21 CFR820, the eQMS fast-tracks the development of organization’s procedures and processes for regulatory compliance.
Embedded Guidance for Customizing Your QMS
The SoftComply eQMS comes with a complete “Example QMS” taken from real industry cases. Info-boxes, Warnings and Notes suggest best practices on how to make the best use of your Quality System.
Supporting media
More details
This is a LIMITED TRIAL VIEW of the SoftComply eQMS for Confluence Cloud users. BOOK A LIVE DEMO CALL to see how the Cloud eQMS Solution works.
Based on ISO13485, IEC62304, FDA 21CFR 820 & TGA, the SoftComply eQMS fast-tracks the development of organisation’s procedures for compliance - a full Quality System for medical device companies.
Includes a Quality Manual, Quality Policy, 25 SOPs & 77 templates pre-filled to fast-track the implementation of QMS.
Fully customisable with guidance on finalising the documents.
The fastest path to a compliant Quality System.
BOOK A LIVE DEMO to view the entire eQMS content & to learn how we can help customise your Confluence instance with compliant document workflows and e-signatures. Check out the short clip on the Cloud eQMS Solution.
Cloud eQMS can be purchased directly from SoftComply. Pricing here.
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Resources
Descriptor
Get the descriptor file downloaded to your system
App documentation
Comprehensive set of documentation from the partner on how this app works
EULA
Get the End User License Agreement for this app
Privacy and Security
Privacy policy
Atlassian's privacy policy is not applicable to the use of this app. Please refer to the privacy policy provided by this app's partner.
Partner privacy policySecurity program
This app is part of the Marketplace Bug Bounty program.
About Bug Bounty programIntegration permissions
SoftComply eQMS (MedTech QMS Starter Pack) integrates with your Atlassian product
Version information
Version 1.0.4-AC•for Confluence Cloud
- Release date
- May 31st 2021
- Summary
- Minor version update
- Details
Minor version update
- Payment model
- Free
- License type
- Commercial