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.
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.
Manual test stations for medical pneumatic valves
EXCO provides support for the modernization of test stations with a complete solution.
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.
Ensuring conformity of quality documentation and audit preparation
EXCO checks the methods of product release to FDA standards in the analytical laboratory sector. Methods are validated; instruments and appliances are qualified.
Development and commissioning of test stations
In order to fulfil highest quality standards in production, EXCO is devloping test stations for blood glucose meters.
