As your competent OEM partner, we support you to turn your ideas into a product, and we are your partner with regard to make-to-order manufacturing and service.
Everything from a single source – the most efficient way for you to receive your device!
Why not benefit from our experiences?
- Long-term experiences in developing and manufacturing products for life science and medical engineering
- The highest quality standards – certified, checked, and applied daily!
- Precise controlling in order to implement projects by observing schedule and cost budgeting
- Certified according to DIN EN ISO 13485
- Company has passed FDA audit
- Standards-compliant planning and documentation of the whole development process (
- design history file)
- Software life cycle processes according to DIN EN 62304:2007-03
- Process and device validation
- Type tests, e.g. climatic test, storage test, vibration test, and transport test
- Process monitoring, defect tracking, CAPA, 8D (device history record)
- Simulation and creation of test strategies and their implementation
- Development and making of complex test instruments
- Change control management
- Monitoring of the suppliers
With our customers, we make agreements on quality assurance including special requirements with regard to the devices and their approval.