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; and 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! For more information, please visit our site: https://softcomply.com
PEDCO – Managed Process Services is a public limited company based in Zurich, Switzerland and collaboration partner of Scaled Agile Inc., Boulder (USA) and Method Park, Erlangen (Germany). We support enterprises around the globe for process implementations within regulatory environments. We offer a comprehensive range of solutions to set-up, select, operate, and develop lean, compliant and efficient processes.
Our mission is to help system and software-dependent enterprises achieve better business outcomes, increase employee engagement, and improve economics through the application of Lean-Agile principles and practices with Applied SAFe® based on the Scaled Agile Framework® (SAFe®).
Applied SAFe® is a stand-alone product from PEDCO. It is a fully fledged ALM tool agnostic implementation of the Scaled Agile Framework (SAFe®) as a process model and kept in sync with the actual SAFe® version by Scaled Agile Inc. (SAI). Together with our partners, we ensure a smooth transition to agile, lean, efficient and compliant processes with Applied SAFe.
PEDCO – Compliance and efficiency for your processes