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.
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.
UDI Implementation
EXCO is validating and testing the Unique Device Identification Database for a client.
Using biological markers
Biomarkers in point-of-care devices using standardized reaction sequences are verified with a specific method.
