A high reproducibility of the manufacturing processes and tests that accompany production are indispensable for achieving best quality. For us, certification according to ISO 9001/2015 and ISO EN 13485/2016 for medical products forms the guidelines with regard to defining the manufacturing processes and tests.
For medical technology products, we offer you validation of the entire process chain in accordance with ISO EN 13485. We define component-specific tests according to customer requirements and incorporate them into the entire manufacturing process.
