SoftComply
About
We help the regulated industries like the medical device developers get their innovative products to market faster by offering Atlassian apps for regulatory compliance. Our apps speed up the compliance process, e.g. CE-marking and FDA approval process. As such, we offer Cloud eQMS Solution on Confluence for the medical device and digital health companies. We also offer the most advanced risk management solutions on Jira with several out-of-the-box risk reports.
Silver Marketplace Partner
This partner participates in Atlassian's Marketplace Security Bug Bounty Program, and invests in Cloud and Data Center versions of their most popular server apps.
Apps by SoftComply
SoftComply Risk Manager for Basic Product Risk Management
🚀 Simple yet Powerful Risk Management in Jira with customisable Risk Matrix & Risk Register + Report Risks in Confluence
641
SoftComply Risk Manager Plus for Advanced Risk Management
Risk Register for GRC, ISO27001, NIST, CVSS, FDA & MDR Cybersecurity, FMEA and Hazard Analysis with Templates & Traceability
498
SoftComply eQMS (MedTech QMS Starter Pack)
Contact SoftComply to get FDA, MDR, TGA & Canada MDR Compliant Quality System Docs for ISO13485, IEC62304, ISO14971, 21 CFR 820
357
SoftComply Static Snapshots to Freeze Pages in Confluence
Capture & Freeze the Dynamic Content of Confluence with the SoftComply Static Snapshots app
144
SoftComply Change History
Add a Change History Table to a Confluence page & capture version and approval history from the Comala Document Management
99
SoftComply Document Manager for MedTech Document Management
Control your Product & QMS Documents with the only validated Document Management app compliant with MDR, IVDR, 21 CFR 11
100
SoftComply Validation for Confluence (MedTech Compliance)
Ensure your Audit-Readiness at all times with the SoftComply Validation app for Confluence Cloud
63
SoftComply Risk Manager for Confluence (for Risk Reporting)
📉 SoftComply Risk Management Reporting Extension for Confluence
438
SoftComply Information Security Risk Manager
Dedicated InfoSec Risk app for ISO27001, NIST, CVSS, FDA and MDR Cybersecurity & Traceability of Assets, Risks and Controls
41
SoftComply Toolbox for Confluence
Additional smart tools to enhance Confluence automation
119
SoftComply Validation for Risk Manager Plus
Automated Validation App for SoftComply Risk Manager Plus
18