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.
Verification and validation of COVID-19 Rapid Tests
EXCO supported a security technology manufacturer with the compliant market introduction of a SARS-CoV-2 rapid test.
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.
EU conformity assessment procedure
EXCO supported the implementation of the EU conformity assessment procedure to enable the legally compliant placement of products on the market. The project ensured that all requirements of the Machinery Directive (2006/42/EC) were met and documented in accordance with applicable regulations.
Development of test procedures
EXCO supported the approval of a medical device in China by developing the required test procedures. The project ensured that testing activities were clearly defined and documented to support the regulatory approval process.
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.
