HOW BIOME DX AUTOMATED THEIR COMPLIANCE WITH SOFTCOMPLY RISK MANAGER ON JIRA CLOUD AND SOFTCOMPLY EQMS ON CONFLUENCE CLOUD
This is the story about Biome Diagnostics, an Austrian medtech start-up that offers medical diagnostic software to doctors that utilizes the genetic information of the microbiome and AI.
Biome Dx automated regulatory compliance on Atlassian Jira and Confluence Cloud with the SoftComply Risk Manager and the SoftComply eQMS apps and became the very first company in the world in the field of microbiome to be certified with ISO13485.
CUSTOMER STORY OF XRGO AND COMPLIANT PPE MANUFACTURING
This story is about XRGO, a contract manufacturer of electronics, audio products and other consumer goods in fitness since 2008 that started manufacturing PPE in USA as a response to the Covid pandemic. XRGO needed to implement a compliant Quality Management System for their PPE manufacturing and this story is about their regulatory compliance journey with SoftComply.
CUSTOMER STORY OF CIBILTECH BECOMING FDA 21 CFR 11 COMPLIANT WITH THE MEDICOMPLI SOLUTION
This story is about Cibiltech, a French medical device company developing an AI based personalized medicine solution for better patient care. Their most recent solution is aimed at post-transplant kidney monitoring for personalized treatment and better decision support. Cibiltech needed to become FDA 21 CFR 11 compliant to access the US market and this story is about their regulatory compliance journey with the MediCompli Solution.
CUSTOMER STORY OF MUNEVO WHO FAST-TRACKED THEIR CE-MARKING PROCESS WITH THE SOFTCOMPLY eQMS
This story is about Munevo, the first wheelchair control system developer that uses smart glasses enabling people to become more independent and safely drive their wheelchair handsfree. Munevo needed to get their product CE-marked to place it on the market and this is the story about their regulatory compliance journey with the SoftComply eQMS.