Expert regulatory consulting regarding electrical safety testing for medical devices to meet IEC 60601 standards and ensure compliance.
If medical devices include electrical components powered by batteries or a power plug (active medical devices), their electrical safety must be assessed. Few areas in medical device regulation have as many safety standards as electrical safety for medical devices. Demonstrating electrical safety and electromagnetic compatibility (EMC) is essential to meet regulatory requirements.
Active medical devices must comply with IEC 60601-1, a key standard for electrical medical device safety. Manufacturers need to define basic safety and essential performance requirements (EPR) as part of their compliance documentation.
To ensure medical device safety testing meets requirements, it is crucial to identify the applicable electrical safety testing for medical devices and conduct the right assessments. This includes EMC testing to confirm that the electrical equipment does not interfere with other active medical devices in its vicinity.
At MedQAIR, our seasoned electrical safety consultants for medical devices provide expert guidance in selecting the right 60601 standards, assessing electrical safety risks, and determining the necessary test suite for compliance. Our regulatory consulting ensures that manufacturers meet all safety and performance requirements efficiently.
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