The Analytical Evaluation Threshold (AET) is the crucial parameter for demonstrating that your analytical results sufficiently assess the biological safety…
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Last month (December 2021) the FDA published draft guidance regarding Digital Health Technologies for Remote Data Acquisition in Clinical Investigations.…
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The FDA has recently published draft guidance regarding the content of premarket submissions for device software functions. The guidance provides…
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Keeping track of the ongoing guidance for MDR adherence can be a time-consuming task. So to simplify your information-gathering process,…
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Producing effective Technical Documentation provides manufacturers with their own central information source regarding their medical device. Accurate Technical Documentation can…
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Within the medical devices field, you may have come across terms like “FDA registered”, “FDA certified” and “FDA Registration Certificate”.…
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A 513(g) request for information is a means for medical device manufacturers to obtain information about the FDA’s views regarding…
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The process of classifying a medical device in the US involves reviewing the potential regulatory class (I, II or III),…
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