Feb 23, 2023
FDA
The document outlines the key points related to the Maltese regulatory requirements in the sphere of medical devices. In particular, the guidance addresses the matters associated with the fees payable by the parties responsible for medical devices intended to be...
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Feb 17, 2023
FDA
The new article describes in detail the aspects related to the measurements to be performed in the course of clinical investigations for neonatal products, including the duration and timing. Table Of Contents: The Food and Drug Administration (FDA or the Agency), the...
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Feb 17, 2023
FDA
The new article highlights the aspects related to the key considerations related to the study design. Table Of Contents: The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a draft...
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Feb 15, 2023
Uncategorized
Over the past few decades, there has been a significant evolution in medical devices in the healthcare industry. Medical devices are an important aspect of healthcare as they help diagnose, monitor, and treat a wide range of medical conditions. These devices include...
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Feb 15, 2023
FDA
Medical devices are an essential component of modern healthcare, and their safety and efficacy are crucial for the well-being of patients. To ensure that medical devices are safe for use and meet certain quality standards, the Food and Drug Administration (FDA) in the...
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