The International Organization for Standardization (ISO) 10993 series provides guidelines for the biological evaluation of medical devices, ensuring the safety from their intended use. This series ...
On February 2, 2024, the US Food and Drug Administration (FDA) published a much-awaited final rule: the Quality Management System Regulation (QMSR). 1 By issuing this rule, FDA amended the medical ...
Taking a proactive approach to compliance can help minimize regulatory risks, avoid submission delays, and ensure continued ...
Over the last 15 years, ISO 10993-18 has become a notable resource for professionals at each stage in the supply chain and manufacturing of medical devices, assisting them in the evaluation of ...
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