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.
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.
Development of a blood glucose meter
A client has modified the hardware of their blood glucose meter. EXCO is supporting the design of the medical device and developing production and test stations.
Safety testing of IVD, laboratory and medical equipment
EXCO is completing the required electrical measurements of devices together with the mechanical tests to ensure conformity to standards.
Gap analysis for existing product files
Gaps have been identified in the documentation of existing product lines. EXCO is creating a requirements list in order to close the gaps. The subsequent TÜV audit has been successfully passed.
Organization of an FDA audit
EXCO is preparing a customer for a pending FDA audit. EXCO is creating a detailed audit plan based on FDA 21 CFR Part 820 requirements and is completing a mock audit.
Preparation of an EU Declaration of Conformity for a test station
EXCO is commissioned with testing production safety and drawing up the EU conformity declaration.
