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.

48 Projects

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

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

eCRF development and implementation for clinical data management

EXCO designs, specifies, develops, and implements eCRFs based on study protocols, enabling clinical trial data to be collected in accordance with high quality standards.

Applications: Computer Systems, Medical Devices, Software
Service: Development, Validation, Verification
Industry: Medical Technology

Open project

Cybersecurity checklist for hearing aid software

EXCO developed a checklist for conducting a comprehensive risk assessment after several audit deviations in the area of cybersecurity were identified at the customer's site.

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

Open project

Cybersecurity checklist for Microsoft Azure DevOps

As part of the tool validation process, EXCO supported the customer in introducing Microsoft Azure DevOps and checked the configuration with regard to cybersecurity.

Service: Development
Industry: Medical Technology
Applications: Software

Open project

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