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

Verification and validation of COVID-19 Rapid Tests

EXCO supported a security technology manufacturer with the compliant market introduction of a SARS-CoV-2 rapid test.

Open project

NIS 2 Compliance Checklist (Cybersecurity)

EXCO developed a comprehensive NIS 2 readiness checklist covering all relevant requirements of the NIS 2 Directive. The checklist enables organizations to assess their current cybersecurity maturity, identify gaps, and evaluate their level of compliance against the directive's requirements.

Service: Consulting
Industry: Medical Technology, Pharma

Open project

Internal audits for SMEs

EXCO supports customers in conducting internal audits in accordance with EN ISO 13485:2016/A11:2021, Section 8.2.4, and in preparing audit documentation that meets applicable standard requirements.

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

Open project

EU conformity assessment procedure

EXCO supported the implementation of the EU conformity assessment procedure to enable the legally compliant placement of products on the market. The project ensured that all requirements of the Machinery Directive (2006/42/EC) were met and documented in accordance with applicable regulations.

Open project

Development of test procedures

EXCO supported the approval of a medical device in China by developing the required test procedures. The project ensured that testing activities were clearly defined and documented to support the regulatory approval process.

Open project

Implementation of a QMS in accordance with DIN EN ISO 13485

In collaboration with EXCO, a client is implementing a quality management system in compliance with DIN EN ISO 13485.

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

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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