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.
15 Projects
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.
Service: Consulting, Licensing
Applications: Equipment & Systems, Medical Devices, Software
Industry: Medical Technology
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.
Service: Consulting, Licensing
Applications: Equipment & Systems, Medical Devices, Software
Industry: Medical Technology
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.
Service: Consulting, Licensing, Qualification
Applications: Equipment & Systems, Medical Devices, Software
Industry: Medical Technology
