ISO 13485:2016 Certification

The ISO 13485:2016 standard ensures that all medical devices meet the proper regulatory compliance laws and customer needs.

The scope of the ISO 13485:2016 certification is for the quality management system of De Novo Software and is applicable to the design, development, and distribution of Flow Cytometry software.

If you have any questions about FCSE with regard to ISO 13485:2016 certification, please contact De Novo Software.

Download our Certificate of Registration for ISO 13485:2016