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Medical Device testing evaluates a medical product’s performance and safety to ensure safety for patients and operators, while simultaneously evaluating the cost-benefit of existing hazards and potential benefits. Medical Device testing consists of a series of safety and EMC tests are performed to prove that a product will not suffer from interference in the applicable medical environment and will prevent unacceptable risks to patients.

A risk assessment is also performed by the manufacturer and submitted to a test laboratory in the form of a risk management document. This document provides evidence that a manufacturers has considered all potential hazards and mitigated associated risks to the highest degree possible. The general testing requirements for most electronic medical devices can be found inside the IEC 60601 standard family.