ISO 13485 certificate 

We are aiming to supply the highest product and service quality to our clients. ISO 13485 specifies the requirements for a quality management (QM) system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and international regulatory requirements. SCARLETRED has obtained ISO 13485 certification in April 2019, an important and big step towards business scale up.

Our product, Scarletred®Vision is also CE medical device marked, enables to convert an ICH-GCP compliant process work-flow and is in alignment with GDPR.

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