Testing and Certifying Medical Devices for Worldwide Market Access
The medical industry is rapidly adopting new technology, which enables better communication and performance of products and systems to improve patient safety. As medical device regulations continuously change, manufacturers face a number of compliance challenges, such as ensuring conformity of your medical electrical equipment to safety standards. Electronic devices used in medical environments have important safety and performance requirements to ensure safety and compatibility with other critical care equipment. These devices also need to reduce unacceptable risk to patients. This is critical for domestic or global product approval.
Stringent regional approval procedures for electrical medical devices typically require independent third-party testing by an approved laboratory to the IEC 60601 standard. Certifying medical electrical equipment requires a deep level of understanding.
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