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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FDA ASCA Pilot Program is expected to bring medical devices to patients and users more efficiently by using ASCA-accredited labs.
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How FDA Breakthrough Devices Program provides advantages for novel devices and can significantly reduce a product’s time to market.
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9 tips for 510(k) submission along with lessons learned from a recent successful experience submitting a medical device to the FDA.
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6 benefits mean the FDA program for breakthrough medical devices may be your best regulatory option for novel medical devices.
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Start early to avoid surprises when preparing for MDR 2017/745. The new EU medical device regulations will come into full force in Q2 2020.
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The final rule for clinical trial information reporting published by US National Institutes of Health and DHHS now includes medical devices.
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Adaptive studies can be especially useful in the pivotal stage if there are uncertainties about one or two aspects of the study.
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FDA final rule on symbols is an important step towards global medical device harmonization and hopefully for a decrease in manufacturing costs as well.
