EXCO - Your Trusted Partner for ISO-Certified Quality
Discover our project references and learn how we support our customers in GxP-regulated environments with proven, practical solutions.
eCRF development and implementation for clinical data management
EXCO designs, specifies, develops, and implements eCRFs based on study protocols, enabling clinical trial data to be collected in accordance with high quality standards.
Cybersecurity checklist for hearing aid software
EXCO developed a checklist for conducting a comprehensive risk assessment after several audit deviations in the area of cybersecurity were identified at the customer's site.
Cybersecurity checklist for authorisation within the EU
As part of the approval process, EXCO was commissioned to test the cybersecurity of a medical device (a laser hair removal device).
Medical device approval (FDA) with a focus on cybersecurity
EXCO provided cybersecurity support to the client in connection with FDA approval of an operating-theatre medical device under the eSTAR programme.
Design verification for a point-of-care device
EXCO provides support in the verification process of a glucose measuring device.
New QM-system for start-up
For a manufacturer of sterile medical products, EXCO creates a customized QM system according to 13485 and establishes the system within the customer organization.