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.
NIS 2 Compliance Checklist (Cybersecurity)
EXCO developed a comprehensive NIS 2 readiness checklist covering all relevant requirements of the NIS 2 Directive. The checklist enables organizations to assess their current cybersecurity maturity, identify gaps, and evaluate their level of compliance against the directive's requirements.
Internal audits for SMEs
EXCO supports customers in conducting internal audits in accordance with EN ISO 13485:2016/A11:2021, Section 8.2.4, and in preparing audit documentation that meets applicable standard requirements.
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.
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 Microsoft Azure DevOps
As part of the tool validation process, EXCO supported the customer in introducing Microsoft Azure DevOps and checked the configuration with regard to cybersecurity.