EMC Testing

We offer EMC test program for active medical devices and/or systems, which defines emission and immunity criteria per IEC 60601-1-2

IEC 60601-1-2:2020 (ed. 4.1) – Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests

You Need Pre-Compliance Evaluation – here’s why

Pre-compliance testing is a valuable tool for product development, as it allows you to proactively identify potential failures

FDA Medical Device Material Performance Requirements – Guide

IEC 60601-1: Everything You Need to Know

Strong foundations are built with robust Quality Management Systems