In the medical device industry, usability plays a critical role in ensuring the safety and effectiveness of highly complex medical products. The IEC 62366-1:2015 standard, which focuses on the ...
The Central Drugs Standard Control Organisation (CDSCO) has launched a new risk classification module on the drug regulator's online system for medical devices in order to simplify the regulatory ...
To support the continued development and marketing of safe and effective medical devices enhanced by artificial intelligence, the U.S. Food and Drug Administration will offer marketing submission ...
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