SoftComply eQMS is a complete Quality Management System based on ISO 13485, IEC 62304, ISO 14971 and 21 CFR 820
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.
Compliant QMS Documents for Each Project
The SoftComply eQMS comes with a number of macros, which will automate some of the most common actions. With a simple interface, these macros will save precious time during the creation of sizeable technical files.
This is a LIMITED TRIAL VIEW of the SoftComply eQMS for Confluence Cloud users.
Based on ISO13485, IEC62304 & 21 CFR 820, the SoftComply eQMS fast-tracks the development of organization’s procedures and processes for regulatory compliance - a complete Quality System for medical device companies.
Includes a Quality Manual, a Quality Policy, 20 SOPs & 70 document templates pre-filled to fast-track the implementation of QMS.
Fully customizable, contains embedded guidance on finalizing the SOPs and technical documents as it includes a finalized QMS based on real industry cases.
The SoftComply eQMS is the fastest path to a compliant Quality System for medical devices.
To view all of the content of the eQMS and how we can help customize your Confluence instance into a compliant eDMS solution, please book a live demo with us.
Try the SoftComply Risk Manager for device risks.
Privacy and security
SoftComply eQMS integrates with your Atlassian product. This remote service can:
- Read data from the host application