SoftComply eQMS - Compliant QMS Documentation
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Key highlights of the appContact SoftComply to get FDA, MDR, TGA & Canada MDR Compliant Quality System Docs for ISO13485, IEC62304, ISO14971, 21 CFR 820
A Fully Customizable Quality Management System
A full Quality Management System for Medical Devices. Based on ISO 13485, IEC 62304 & 21 CFR 820, the SoftComply eQMS fast-tracks the development of your 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.
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More details
A full Quality Management System for Medical Devices - based on ISO13485, IEC62304 & FDA 21 CFR820, the SoftComply eQMS fast-tracks the development of your organisation’s procedures and processes for regulatory compliance.
Includes a Quality Manual, a Quality Policy, 20 SOPs and 77 document templates pre-filled to fast-track the implementation of QMS.
Fully customizable, contains embedded guidance on finalizing the SOPs and technical documents.
The SoftComply eQMS also includes a complete and finalized QMS, the “Example eQMS”, based on real industry cases. You can follow this example to customize the eQMS for your company.
The SoftComply eQMS provides the fastest path to implementing a compliant Quality Management System for medical devices.
Book a LIVE DEMO with us to view the eQMS content & to learn how we can help customise your Confluence instance with compliant workflows and e-signatures.
For full regulatory compliance, try our RISK MANAGEMENT APP for MEDICAL DEVICE RISKS.
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We no longer offer sales and support for server apps. You can still explore the earlier versions but these may not offer the necessary support.