Customer Stories

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.