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.
Fully automated test stations for blood glucose meters
A client is commissioning EXCO with the design and qualification of a fully automated test station.
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.
Meeting requirements
A client is commissioning EXCO with the qualification of test stations and validation of a product line for a blood glucose meter.
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.
