Regulatory Documentation

INVIA Solutions is dedicated to maintaining the highest standards of quality, security, and regulatory compliance. Below, you will find our certifications and quality documents for easy reference.

Certifications

ISO 13485:2016

MDD-Directive 93/42/EEC

Compliance Records

Regulatory Compliance Record

SOC 2 

Corridor4DM Software Bill of Material

Cybersecurity Surveillance Log

Translated Instructions For Use

v2025 IFU

v2024 IFU

v2023 IFU

v2018 IFU

v2017 IFU

v2016 IFU