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

MDSAP ISO 13485:2016

Certification under the Medical Device Single Audit Program.

MDD Certification

Certification under the Medical Device Directive (MDD).

Directive 93/42/EEC

Compliance with the European Medical Devices Directive.

ISO 13485:2016

International quality management standard for medical devices.

Compliance Records

SOC 2 

System and Organization Controls 2 is a cybersecurity compliance framework that aims to ensure an organization securely manages customer data. 

Corridor4DM Software Bill of Material

Revision: 3.8
28-July-2025

Cybersecurity Surveillance Log

Ongoing cybersecurity monitoring and logging for data protection.

Regulatory Compliance Record

Documentation of adherence to international regulatory standards.

Translated Instructions For Use

v2025 Instructions for Use

v2024 Instructions for Use

v2023 Instructions for Use

v2018 Instructions for Use

v2017 Instructions for Use

v2016 Instructions for Use

v2015 Instructions for Use

v2017 Instructions for Installation

v2016 Instructions for Installation

v2015 Instructions for Installation