SoftComply

SoftComply aims to speed up the regulatory compliance of medical devices so that the innovative products can be placed on the market faster and cheaper. To that end, SoftComply automates regulatory compliance and integrates it to the agile software development environment ensuring the safety and compliance of medical device innovations. SoftComply offers Atlassian add-ons for medical device and other regulated industries: 1) SoftComply Risk Manager is an add-on for Jira that automates product risk management and integrates it to the software development environment for full traceability; 2) SoftComply eQMS to kickstart medical device quality system documentation as an add-on for Confluence. SoftComply's regulatory compliance software solution speeds up medical device CE-marking and FDA approval process while cutting compliance costs by 10 times!