Regulatory Information

Smart Labs achieved not just one, but two significant certifications that reinforce our commitment to delivering the highest quality in software-as-a-medical-device (SaMD) manufacturing and distribution.

Firstly, we proudly announce that we have successfully attained the ISO 13485 certification for our Quality Management System (QMS). ISO 13485 is an internationally recognized standard designed to ensure that medical device manufacturers adhere to stringent quality requirements. By achieving this certification, we have demonstrated our compliance with rigorous standards and our commitment to consistently meeting customer expectations while adhering to regulatory guidelines.

In addition to the ISO 13485 certification, we are delighted to inform you that we have also attained the coveted MDSAP (Medical Device Single Audit Program) certification. MDSAP is an internationally recognized program that allows medical device manufacturers to undergo a single audit that satisfies the requirements of multiple regulatory authorities, including the U.S. FDA, Health Canada, TGA (Australia), ANVISA (Brazil), and PMDA (Japan).

Customy Vision is certified as software as a medical device supporting diagnostics, by TÜV Rheinland LGA Products GmbH, a notified body according to Regulation (EU) 2017/745 concerning medical devices with identification number 0197.