EXCO - Your Certified Partner for MedTech, Pharma & Life Sciences
Since 1994, EXCO has been developing components, software, assemblies, and test systems for medical devices and in vitro diagnostics. Our services cover the entire development process, from concept development and embedded software (IEC 62304) to design verification and regulatory approval (MDR, IVDR). More than 200 employees across eight EXCO locations support the entire lifecycle of your medical device while ensuring the highest quality standards.
As an ISO-certified company (ISO 13485 and ISO 9001), EXCO's experts ensure that your hardware and software reliably meet all specified requirements. Through comprehensive verification activities, we not only ensure compliance with applicable regulatory requirements but also demonstrate the safety, robustness, and high usability of your systems.
EXCO Services
Medical Device Services
Medical Device Development
With our DIN EN ISO 13485 certification and many years of expertise, we are your trusted partner for the development of innovative and safe medical devices.
Our services:
- Concept development and prototyping
- Software as a Medical Device (SaMD) in accordance with IEC 62304
- Electronic component and assembly design
- Embedded software, firmware, and app development for medical devices
- Mechanical engineering and design
Design Verification: Hardware and Software Testing
EXCO supports the development of safe, standards-compliant medical devices through comprehensive hardware and software testing. Our experts ensure that your products meet all applicable requirements and standards, including IEC 60601, IEC 62304, DIN EN 55011, DIN EN 60068-X, IEC 61000-X, and IEC 62366.
Hardware Testing services:
- Mechanical testing, environmental testing, and electromagnetic compatibility (EMC) testing in the customer’s own laboratory
- Management and coordination of testing at accredited laboratories
- Preparation of technical documentation in accordance with applicable regulatory requirements, including MDR and IVDR
- Robot-based testing. Learn more: Robot-Based Testing with MoRTIE
Software Testing services:
- Test case development for manual and automated software testing
- Development of test frameworks for efficient test automation
- Integration testing, system testing, and ad hoc testing
- Code reviews
- Preparation of quality documentation for medical devices
Customized Lab-Automation
Standard automation solutions don’t fit your lab? Guided by your workflows, we design customized automation solutions that integrate seamlessly into your lab environment. From concept and development to implementation and ongoing support, EXCO is your trusted partner for reliable, tailored solutions across all challenges in lab and R&D automation.
Your benefits through efficient Lab-Automation:
- Tailor-made lab-automation designed to meet your specific requirements
- End-to-end consulting, strategic planning, and feasibility assessment
- Seamless integration into existing processes, infrastructure, and systems
- Enhanced efficiency and productivity through intelligent automation
- Regulatory compliance (e.g. ISO 13485, IEC 62304, IEC 61010, GMP requirements)
- Comprehensive support for qualification, validation, and documentation
- Reliable long-term support and continuous improvement
Product Safety
We help ensure the safety, compliance, and market readiness of your medical devices through comprehensive device safety and usability engineering services. As specialists in usability evaluations for medical devices, we also ensure that your medical devices meet stringent regulatory requirements.
Our services:
- Identification of applicable standards for your product
- Usability evaluations in accordance with IEC 62366 and FDA requirements
- Ensuring regulatory compliance with MDR, IVDR, IEC 62304, and ISO 13485
- Support for device safety testing, including mechanical testing, electrical testing, usability evaluations, climate testing, and EMC testing in accredited environments (EN ISO 17025)
- Risk management
- Evaluation of test results
- Document review
- Preparation of technical documentation, including test reports, technical reports, and related documents
- Consulting on device safety
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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