Technical service provider for quality assurance, test and production equipment, software and validation in regulated industries.
EXCO GmbH
Frankenthal (Adam-Opel-Str. 9-11) · Ludwigshafen am Rhein (Donnersbergweg 3) · Jena (Neugasse 21) · Root Längenbold near Lucerne, CHNew on Amplifa
About EXCO
EXCO GmbH, based in Frankenthal, is a technical service provider for quality assurance, automation and development. The company plans and implements test, manufacturing and production processes, develops software and system solutions, and supplies test and production equipment for the manufacture of medical devices and in-vitro diagnostics, including robot-based physical test systems and automated function testers for printed circuit boards. The service portfolio also includes Computer System Validation (CSV), test automation, cybersecurity for medical devices, MDR/IVDR compliance, laboratory analytics, process validation, and the qualification of production lines, special machinery and IT infrastructures in accordance with GAMP-5. Customers are group companies, leading manufacturers and system suppliers from the medical, pharmaceutical, biotech, food and chemical industries. The owner-managed, mid-sized company has been active in the market for over 25 years and is represented at locations in Frankenthal, Ludwigshafen and Jena as well as by EXCO Consulting GmbH in Root near Lucerne (Switzerland).
- Site
- Frankenthal
- Processes
- Development of test and production equipment, Development of test and inspection processes, Automated function testers for PCBs (blood glucose meters), Test automation, Robot-based physical testing for product development, verification or validation, Manufacture of test and production equipment, Qualification of production lines according to GAMP-5, Qualification of special machinery / systems / test benches according to GAMP-5
- Materials
- Computer System Validation, Qualification according to GAMP-5, Risk analyses, Process and Building Control Technology, Machine Safety and ESD
- Certificates
- ISO 9001:2015, ISO 13485:2016 (EN ISO 13485:2016/AC:2018, A11:2021), ISO 9001, ISO 13485
- Industries
- Medical technology, Pharmaceuticals/In-vitro diagnostics, Biotechnology, Food technology, Chemical industry
- 01
Requirements Engineering
- 02
Design and development of components, manufacturing processes and software
- 03
Manufacture of test and production equipment
- 04
Test automation and robot-based physical testing
- 05
Qualification and validation of processes, systems and IT systems
- 06
Regulatory Affairs and training
Services and Processes
Computer System Validation
Validation of computerized systems in regulated environments across the entire lifecycle.
Qualification according to GAMP-5
Qualification of production lines, special machinery, systems and test benches.
Risk analyses
Facilitation and evaluation of risk analyses using the FMEA method.
Process and Building Control Technology
Planning of process and building control technology for industrial systems.
Machine Safety and ESD
Services for machine safety and electrostatic discharge.
Locations
Frankenthal
DECompany headquarters/head office
- Robot-based physical test systems
- Automated function testers for PCBs
- Photovoltaic system (170 modules, 62 kWp)
Ludwigshafen am Rhein
DEPlanning of process and building control technology
Jena
DEQM services, machine safety/ESD, Design & Regulatory Affairs
- Robot-based physical test systems
Root Längenbold (near Lucerne)
CHEXCO Consulting GmbH location serving the Swiss market
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Development of test and production equipmentEngineering | – | – | – | – | – |
| Development of test and inspection processesTesting | – | – | – | – | – |
| Automated function testers for PCBs (blood glucose meters)Testing | – | – | – | – | – |
| Test automationTesting | – | – | – | – | – |
| Robot-based physical testing for product development, verification or validationTesting | – | – | – | – | Medical devices, In-vitro diagnostics |
| Manufacture of test and production equipmentEngineering | – | – | – | – | – |
| Qualification of production lines according to GAMP-5Engineering | – | – | – | – | – |
| Qualification of special machinery / systems / test benches according to GAMP-5Engineering | – | – | – | – | – |
| Process validation and supplier developmentEngineering | – | – | – | – | – |
| IT infrastructure qualificationEngineering | – | – | – | – | – |
| Validation of computerized systems (CSV)Testing | – | – | – | – | – |
| Compressed air system qualification (medical compressed air)Engineering | – | – | – | – | – |
| Laboratory analyticsTesting | – | – | – | – | – |
| Qualification of analytical instrumentsTesting | – | – | – | – | – |
| Method development and validation for laboratory diagnostics (biomarkers in point-of-care devices)Testing | – | – | – | – | – |
| Software development (Agile, Embedded, medical device software)Engineering | – | – | – | – | – |
| Risk analyses using the FMEA method (facilitation and evaluation)Engineering | – | – | – | – | – |
| Services for machine safety and electrostatic discharge (ESD)Engineering | – | – | – | – | – |
| Planning of process and building control technology (PLT)Engineering | – | – | – | – | – |
| Services for maintenance and process controlsEngineering | – | – | – | – | – |
| System integration in complex electronic products / hardware for test systemsAssembly | – | – | – | – | – |
| Qualification of testing systems in the GMP environmentEngineering | – | – | – | – | – |
| Software for measurement series and studies (medical devices)Engineering | – | – | – | – | – |
3 Anlagen & Maschinen
| Machine | Manufacturer / model | Quantity | Working area | Year built | Site |
|---|---|---|---|---|---|
| Robot-based physical test systems | – | – | – | – | Frankenthal / Jena |
| Photovoltaic system | – | 170 module | approx. 300 m² roof area, 62 kWp, approx. 63,000 kWh/year | 2021 | Frankenthal |
| Automated function tester for PCBs | – | – | – | – | – |
Additional services
Reference customers
Quality
EXCO has been certified according to DIN EN ISO 9001:2015 since 2000 and according to DIN EN ISO 13485:2016 since October 2009 (TÜV SÜD); the certificates were renewed from 2026 to 2029. The company-wide quality management system is reviewed annually in the management review and continuously adapted to new requirements.
| Evidence | Frankenthal | Ludwigshafen am Rhein | Jena |
|---|---|---|---|
| ISO 9001 | |||
| ISO 13485 |
History
- 2000
Introduction of a company-wide quality management system; ISO 9001 certification since 2000
- 2009
ISO 13485 certification since October 2009
- 2021
Commissioning of the photovoltaic system (62 kWp, approx. 63,000 kWh/year) at the Frankenthal headquarters
- 2026
Renewal of the ISO 9001 and ISO 13485 certificates (valid until 2029)