Regulatory Information

Electronic versions of Instructions

Medical Certification

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.

Instructions For Use

Electronic versions of the Instructions for Use (IFU) for Customy Vision Software 1.1.0 are available to download in an electronic format:

Instructions for Use in other languages:

  • Instrukcja Użycia Oprogramowania (Polski)

The minimum requirement for viewing IFU is PDF Viewer.

Version History:

The current release is 1.1.0.

Past Instructions for Use: –

Software Installation Instructions

Electronic versions of the Software Installation Instructions (SII) for Customy Vision are available to download in an electronic format:

  • Software Installation Instructions (English)

Software Installation Instructions in other languages:

  • Instrukcja Instalacji Oprogramowania (Polski)

The minimum requirement for viewing SII is PDF Viewer.

Other Documents

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