A set of final orders issued by the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) on Thursday established new classifications for six device types. The final ...
The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) issued two final orders Thursday, classifying an anesthesiology and an ENT device into class II. The ...
The FDA released their updated guidance on Cybersecurity in medical devices: Quality System Considerations and content for Premarket submissions at the end of June in 2025. In this guidance the FDA ...
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Mastering risk management for safer medical devices
From concept to clinical use, medical device safety depends on proactive risk management. Tools like FMEA help teams identify and prioritize potential failures before they cause harm. Combined with ...
Companies developing or deploying AI systems now face increasing scrutiny around risk classification, transparency and lifecycle governance. An AI management system (AIMS) aligned with ISO/IEC 42001 ...
Draft guidelines aim to align India's medtech software framework with global practices; industry seeks more clarity on AI/ML ...
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