EXCO References

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.

77 Projects

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

Migration of a process control system

EXCO offers customized solutions in order to modernize process control systems used in the processing industry.

Service: Engineering Services
Applications: Equipment & Systems

Open project

UDI Implementation

EXCO is validating and testing the Unique Device Identification Database for a client.

Applications: Computer Systems
Industry: Medical Technology
Service: Validation

Open project

Migration of process control systems at existing facilities

Migration of control systems: EXCO automation specialists are updating an existing control system.

Service: Engineering Services
Applications: Equipment & Systems

Open project

Laboratory environment supporting conformity assessment, regulatory approval, and market access under MDR and IVDR.

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As a full-service provider, we support SMEs and large corporations with high-quality technical solutions in software engineering, systems development, automation, and quality assurance for highly regulated markets. Our customers include companies in the medical technology, pharmaceutical technology, biotechnology, chemical, and food technology sectors, as well as other regulated industries.

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