Quality assurance and Certification
Certified according to DIN EN ISO 9001 and DIN EN ISO 13485, all of our development and production processes meet the highest requirements on quality assurance, especially on the respective requirements for medical devices.
- Simulation and establishment of test strategies and their realization
- Development and realization of complex test devices
- Type testing, such as environmental, storage, vibration and transport testing
- Templates, documentation and accompaniment of the certification process and approval, according to TÜV (German technical inspection association), UL, CDRH, EMC (electromagnetic compatibility), VDE (German Association for Electrical, Electronic and Information Technologies), and others, for medical devices and according to the requirements of the FDA (Food & Drug Administration) on production plants for medical devices