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.
Implementation of a QMS in accordance with DIN EN ISO 13485
In collaboration with EXCO, a client is implementing a quality management system in compliance with DIN EN ISO 13485.
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.
CSV validation for software in the pharmaceutical environment
A client is developing software in the pharmaceutical sector and requires support to ensure that the software validation process is designed in compliance with regulatory requirements.
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.
