Referenzprojekte

Eine Auswahl 

unserer Projekte

Die folgenden Referenzen geben Ihnen einen Überblick über das Arbeitsumfeld, in dem wir uns bewegen.

6 Projects

Fully automated test stations for blood glucose meters

A client is commissioning EXCO with the design and qualification of a fully automated test station.

Service: Development, Qualification
Applications: Equipment & Systems, Testing Equipment
Industry: Medical Technology

Open project

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.

Applications: Computer Systems, Equipment & Systems, Medical Devices, Software
Service: Consulting, Development, Licensing
Industry: Medical Technology

Open project

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

Open project

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

Open project

Meeting requirements

A client is commissioning EXCO with the qualification of test stations and validation of a product line for a blood glucose meter.

Applications: Equipment & Systems, Processes & Procedures
Industry: Medical Technology
Service: Qualification, Validation

Open project

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

Open project

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