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Functional Safety Testing for Medical Devices & IVDs

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Transform Your Innovation into a Compliant & Marketable Product

Functional Safety 

Functional safety centers on the product's reliability to respond to inputs safely and correctly in addition to assessing potential risks that could arise during use from a design's electrical, mechanical, or other features. It gives confidence that the device's safety-related systems will provide the essential risk reduction to mitigate the severity and likelihood of harm in the event of a malfunction.

Why Functional Safety is Critical?

Given that medical devices can have an impact on the health and wellbeing of users and patients, it is crucial for makers, importers, and resellers to ensure the functional safety of these equipment.

Your business gains from higher market acceptance and favourable brand connections by doing risk analysis and producing medical products that are functionally safe. Serious consequences may result from failing to maintain functional safety.

having their products rejected from these and other markets.

Artixio's Experience

Artixio provides functional safety tests throughout product development cycle - from concept to production using a team of experienced functional safety professionals with decades of experience. 

Artixio's Services

To prevent potential losses from redesign and rework, functional safety should be taken into consideration at every stage of the product development process, especially in the initial design of the product. Every phase of product development is covered by Artixio's functional testing services.

Independent Safety Assessment: A medical device's functional safety concept can be tested by the independent safety assessment (ISA) team of Artixio's experts both during the design phase and after the device is integrated and prototyped. We also provide ISA to assess the overall risk management system's suitability for the strict standards imposed on medical equipment.

Software safety assessment: For both patients and operators, a software error in complex medical devices like MRI and X-Ray machines can be fatal. Because of this, the functional safety programme of Artixio places a strong emphasis on evaluating medical software in accordance with safety standards like IEC 60601 and IEC 62304.

Product Testing: Additionally, we provide environmental testing, electromagnetic compatibility testing, and electrical safety testing services for medical equipment.

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