EXCO - Your Certified Partner for Industry and R&D
Whether for small production runs or high-volume manufacturing, EXCO’s experts develop, verify, and qualify your test systems, measuring equipment, and manufacturing facilities. From equipment qualification (from Design Qualification to Performance Qualification) to process validation, we ensure that your equipment and systems are perfectly aligned with your products and comply with all relevant standards.
EXCO User Storys
From Test System Qualification to a Validated Production Line
Our client from the medical technology industry was looking for a reliable partner to qualify its test systems and validate the production line used for manufacturing medical devices. To support this initiative, the company commissioned EXCO. Our experts carried out the required qualification and validation activities and supported the project through to its successful completion.
What were EXCO’s responsibilities?
- Defining test procedures: Translating requirements into clearly defined, testable verification steps at an early stage.
- Automating tests: Developing automated software tests directly from the specifications.
- Simulating hardware: Executing tests using a simulated interface, independent of the actual production hardware.
- Preparing for qualification: Using development-phase test documentation to support and streamline later qualification activities.
Which technologies and tools were used?
- Proprietary test bench framework with a simulated hardware interface
- Software development in C++ and C#
Customer Benefits
Cost Savings
By leveraging synergies between development and validation, costs were significantly reduced.
Faster Time to Market
Development-phase testing and documented verification activities enabled a faster production line launch.
Reliable Qualification
Automated testing and simulated hardware interfaces enabled reproducible testing throughout the development process.
Strong Partnership with EXCO
Close collaboration between EXCO and the development team enabled optimized test interfaces and more efficient verification processes.
EXCO Services
Our Services
Why EXCO
Why EXCO as Your Partner for Development, Qualification, and Validation?
As an ISO 13485- and ISO 9001-certified company, we develop, qualify, and validate your products and processes in accordance with established quality standards such as GMP and GAMP® 5. We incorporate the requirements of regulated industries from the very beginning, ensuring compliance, quality, and efficiency throughout the entire lifecycle.
With EXCO, you benefit from a comprehensive portfolio of services covering the entire lifecycle of your equipment and systems. From the development of turnkey test and inspection systems and GMP-compliant equipment qualification to process validation, we provide all relevant services from a single source. This reduces interfaces, saves valuable time, and ensures you have one dedicated point of contact throughout every stage of your project.
Explore our full portfolio of services here: EXCO Services
At EXCO, we combine expertise in engineering, computer science, and mathematics. Our interdisciplinary teams support you throughout every phase of your project, working closely with you to develop tailored, practical solutions that meet your specific requirements.
EXCO supports you not only in individual projects but also as a long-term partner in the continuous advancement of your products, processes, and regulatory strategies.
As one of the leading engineering service providers for regulated markets, EXCO combines extensive industry experience with deep technical and regulatory expertise. This enables us to support you throughout the development, qualification, and validation of your products, processes, and systems with confidence and competence.
At EXCO, we do not rely on off-the-shelf solutions. We design and develop test and inspection systems tailored to your products, processes, and individual requirements.
EXCO's Quality Standard
Certified by TÜV SÜD to EN ISO 13485:2016 and DIN EN ISO 9001:2015
EN ISO 13485:2016 - The Provision of Design and Development Services for Components, Semi-Finished Products and Manufacturing Processes for Medical Devices and In Vitro Diagnostics. The Provision of Development Services and of Testing and Production Equipment for the Manufacturing of Medical Devices and In Vitro Diagnostics, including Robot-Based Physical Testing for Use within Product Development, Verification or Validation Activities. The Provision of Regulatory Affairs Services for Medical Devices and In Vitro Diagnostics. The Provision of Qualification and Validation Services for the Manufacturing of Medical Devices and In Vitro Diagnostics.
DIN EN ISO 9001:2015 - Design and development of components, semi-finished products, manufacturing processes, software as well as production of test and production equipment as well as provision of services in laboratory analysis
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EXCO Sevices
EXplore our EXCO Services
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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