Development and qualification of testing and production systems
EXCO develops and qualifies production and testing systems for devices and components, for small batches all the way through to mass production.
Our interdisciplinary teams of engineers, computer scientists and mathematicians will provide you with advice from the very beginning about the design and planning of your systems and carry out your projects to the current state of technology.
Development of test systems
Basic test procedures, test-specific measurement concepts and measurement set-ups are tailored to your needs using standardized components. Software, electronics and mechanics are developed accordingly. The result is that sensor technology, actuator technology and measurement technology are adapted to your specific requirements. Our expertise lies in electrical, mechanical and optical tests in the context of independent equipment and the integration into existing production plants.
Validation and qualification of processes and plants
EXCO is a proven partner in the GMP-compliant validation of your manufacturing and supplier processes and the qualification of your systems and equipment so that traceable and consistent documentation of all sub-processes in the supply chain can be obtained. EXCO will undertake all tasks, ranging from the development of qualification strategies and project management to the creation of the phase-accompanying documentation.
We will undertake qualification for your systems and equipment in the regulated area for assembly stations, in-process controls, syntheses, end-of-line test stations and multi-product and multifunctional systems.
Service portfolio for production facilities and test stands
We develop tailor-made test systems which, thanks to their modular structure, can be efficiently adapted to a wide variety of test requirements.
Standardized development processes, semi-automated and fully-automated test processes, modular test frameworks enable shorter development times for products and systems in highly regulated sectors, such as medical technology and the automotive and aerospace industries.
EXCO is a specialist in the design and development of assembly groups with customer-specific embedded technologies for devices and plants. Our embedded software and hardware are specifically tailored to one another and used from prototypes to series applications in regulated industries.
With process validation, we provide evidence that your manufacturing process has been developed safely and works reliably over the entire duration of the product life cycle. Our individual services:
- Project coordination
- Creation of master validation plan
- Process documentation
- FMEA moderation
- Inspection of product history (FTTR, customer complaints, CAPAs, etc.)
- Master validation report
We will take responsibility for your plant and device qualification in the regulated fields of medical devices and pharmaceuticals. We will ensure special purpose machinery, systems, test stands and production lines are qualified according to GMP and GAMP-5:
- Assembly stations
- In-process checks
- Syntheses
- End-of-line test benches
- Multi-product plants, multi-functional systems
EXCO can guide you through all phases
- Design qualification - DQ
- Installation qualification - IQ
- Operational qualification - OQ
- Performance qualification - PQ
- Support for factory acceptance tests - FAT
- Site acceptance tests at the customer’s premises - SAT
EXCO is a tried-and-tested partner for hospitals, clinics and pharmacies, providing GMP-compliant validation of manufacturing and supplier processes.
Read more about the services we provide for healthcare facilities
As a specialist for the regulated industries, we create GxP-compliant technical documentation. EXCO provides you with support to fulfil the legal requirements for technical documentation according to the applicable directives and laws in the EU, Switzerland and the USA.
In 2017, the new European Medical Device Regulation (MDR) and the EC Directive about In Vitro Diagnostic Medical Devices (IVDR) came into force. These replaced the existing medical product directives.
EXCO can provide you with everything you need to ensure legal development, production and marketing processes with regard to the new requirements and regulations.
Related Topics
-
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.
-
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.
-
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.
-
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.
