Development and Qualification of Test Systems
From small series to large-scale production, we develop, validate, and qualify your testing systems, measuring equipment, and manufacturing facilities. This ensures they are tailored to your products and processes, and comply with industry-specific quality and safety standards, such as ISO 13485, GMP, and GAMP 5.
Our interdisciplinary teams of engineering, computer science, and mathematics experts support you in every phase of your project. We rely on modern technologies, pragmatic solutions, and consistently efficient implementation, always keeping your individual requirements in mind.
Development: Testing & Manufacturing equipment
We develop test systems and measurement concepts that are precisely tailored to your specific testing needs. Thanks to our modular designs and standardized development processes, we can adapt our solutions to different test requirements.
Our services:
- Electrical, mechanical, and optical testing methods
- Test-specific measurement concepts and modular measurement setups
- Development of software, electronics, and mechanics
- Adaptation of sensor, actuator, and measurement technology
- Modular test systems for flexible testing requirements
- Semi- and fully automated test processes
- Use in medical technology, automotive technology, aerospace technology, and aviation technology
Relevant standards: GMP, GAMP 5, ISO 9001, ISO 13485, 21 CFR Part 820
Development: Embedded systems
We develop customized embedded hardware and software for regulated industries, from prototypes to series production, in strict compliance with applicable norms and quality standards.
Our services:
- Design and development of assemblies
- Integration of customer-specific assemblies
- Prototyping to series application
- Modular and scalable embedded architectures
Relevant standards: ISO 9001, ISO 13485
Equipment qualification
We handle the qualification of your plant and equipment in the regulated areas of medical devices and pharmaceuticals. In accordance with GMP and GAMP 5, we qualify special-purpose machines, plants, test benches, and production lines.
- Assembly Stations
- In-Process Controls
- Packaging systems
- End-of-Line Testing Stations
- Multi-Product Systems
- Multifunctional Systems
EXCO guides you through all phases of the process:
- Design Qualification (DQ)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- Support during Factory Acceptance Tests (FAT)
- On-Site Acceptance at the Customer's Premises (SAT)
Process validation
Through process validation, we confirm that your manufacturing process has been developed safely and will operate reliably throughout the product's entire life cycle.
Our services:
- Project coordination, including planning, control, and monitoring
- Creation of master validation plan
- Process documentation of all relevant process steps and results
- FMEA moderation and risk analysis
- Review of product history, including analysis of FTTR, customer complaints, CAPA, and other data sources
- Master validation report
Process solutions
Qualifying process and procedural engineering systems is also part of our service portfolio.
Our services:
- Qualification
- Project management
- Consulting on standards, guidelines, and compliance, including GMP, GAMP 5, and ISO 13485.
Related Topics
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Desktop applications, web applications or mobile apps – we tailor our development to your needs and customize it to suit your processes as client/server, databases or cloud solutions.
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As specialists in component development for medical devices, we are certified in accordance with ISO DIN EN 13485. The products and electronic components for medical devices developed by EXCO meet the highest requirements when it comes to quality assurance and usability.
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We can determine the applicable legal and normative requirements for IT systems and processes and plan, test and document the subsequent review using officially reliable methods.
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EXCO will make your systems, applications and data stronger with a coordinated mix of technical and organisational security measures. We ensure compliance by carrying out tests and providing the relevant technical documentation:
Medical Cyber Security
• Hardened Product Lifecyle
• Legal Compliance in line with MDR/IVDR, IEC 62304 and ISO DIN EN 13485
• Technical Documentation according to MDR IT-SecurityExpert Services
• Threat analysis
• Requirements analysis
• Penetration test
• Vulnerability analysis -
EXCO asseses the quality management of suppliers and ensures that facilities, equipment, and processes of your suppliers are valid according to regulations and guidelines of the regulated industries.
