ISO 13485 Certificates

We produce our products and services in accordance with EN ISO 13485:2016 and in compliance with the applicable regulatory requirements of the European REGULATION (EU) 2017/746 for in vitro diagnostic medical devices. Our quality system is designed to meet stringent regulatory requirements, but flexible enough for us to customize any specific items for your needs.

ISO 13485 Certificate - English (pdf)

ISO 13485 Certificate - German (pdf)

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