Medical Device Development
With our DIN EN ISO 13485 certification and many years of industry expertise, we support you in the development and design verification of medical devices, ensuring full compliance with applicable standards and complete audit-ready documentation.
MDR/IVDR Conformity Assessment
From regulatory strategy and conformity assessment to market access, EXCO helps you meet MDR and IVDR requirements, achieve CE marking, and establish robust quality and risk management systems. We remain a trusted partner throughout the entire product lifecycle, including post-market compliance.
Robot-Based Testing with MoRTIE
With MoRTIE, we automate product testing with consistent, repeatable results while ensuring compliance with applicable standards and MDR requirements. From wipe and load testing to robustness and lifetime testing, every step is fully documented and traceable, providing audit-ready records at all times.
Software Development for Regulated Industries (incl. Qt, C, and C++)
From agile software development to the development of medical device software using Qt, C, and C++, we support the entire lifecycle of your software, from requirements management and architecture through development and testing to validation, documentation, and maintenance.
Software Test Automation for Regulated Industries
Our EXCO specialists develop scalable test automation solutions that integrate seamlessly into your existing development and validation processes. Our service portfolio ranges from development-accompanying testing with CI and Shift-Left approaches to automated regression and performance testing.
Laboratory Information Management Systems (LIMS)
EXCO supports you throughout the entire LIMS lifecycle, from system selection and implementation to computerized system validation (CSV) and the operation of secure, efficient, and automated laboratory environments.
Computer System Validation (CSV)
EXCO supports you throughout the Computer System Validation (CSV) of your IT systems and landscapes. From strategy development and consulting to gap analyses, compliance assessments, implementation, and audit-ready documentation, we ensure your computerized systems remain secure, compliant, and fit for regulatory requirements.
Cybersecurity for Medical Devices
Our experts provide comprehensive cybersecurity and compliance support, including readiness assessments for NIS2. From gap analyses and STRIDE threat modeling to the implementation of tailored security controls, we help you achieve regulatory compliance while enhancing the security and resilience of your business.
Solutions for Manufacturing Processes
From the development of testing, measurement, and manufacturing equipment to turnkey test and inspection systems, qualification, and process validation, EXCO supports you in implementing reliable, GMP-compliant manufacturing processes.
Engineering Services for Process Control Systems (PCS) and Plants
EXCO supports the planning and documentation of complex production processes and manufacturing facilities in the chemical industry, ensuring transparency, end-to-end traceability, and the reliable execution of technical requirements.
