Resource Centre
Discover a wealth of knowledge and insights from the experts at StarFish Medical. Our Resource Centre offers product development tips, reviews of new and cutting-edge technologies, and in-depth articles on regulatory updates and compliance in medical device development.
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Overview of tools for Root Cause Analysis is an important tool in medical device development and manufacturing.
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Predetermined Change Control Plans (PCCPs) Draft Guidance with Implications for Medical Device Manufacturers and regulatory framework
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Originally a practice at only the very largest software houses — like Google and Amazon — continuous integration (CI) has worked its
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The U.S. Food and Drug Administration (FDA) made a significant update to its regulatory approach for in vitro diagnostic products (IVDs), including laboratory developed tests (LDTs). Detailed in a FDA Laboratory Developed Tests Policy guidance document issued on June 25, 2024.
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Drug Delivery Solutions for Cell and Gene Therapy (CGT) Challenges explores effective delivery devices and solutions for advanced CGT therapies and their unique challenges.
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Aerosol Drug Delivery Systems, including Aerosol-based pulmonary-delivered drug devices, offer significant value by enabling targeted drug delivery directly to the respiratory system.
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Drug Delivery System Imaging Technology options include MRI, CT, and Ultrasound. This article highlights advantages and disadvantages for each technology in guiding drug delivery.
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Medical devices for animals are not regulated in the same manner as those for humans. Nevertheless, they are medical devices. This article explore emerging animal medical devices.
