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Most 510(k) submissions will include some type of performance data. The extent of performance data will depend on the complexity Read More
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Section 513(g) of the FDA One of the difficulties that medical device manufacturers encounter is deciding how to proceed with Read More
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Biocompatibility Assessment Device biocompatibility is the ability of a medical device or material to perform with an appropriate host response in Read More
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The following are the information requested by MHRA Registration of Medical Devices. Manufacturer (Facility) Information: Legal manufacturer Name, Address Read More
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Process to Rule out Level of Concern of Software Medical devices for 510(k) Submission Software Level of Concern (LOC) relates Read More
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FDA Registration for New Drug is mandatory if you want to sell OTC and over the counter drug products in Read More
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This blog post has been created for those who want to learn about the importance of CE Marking. We used Read More
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All the scientific articles are gathered together as a primary part of the clinical evaluation. MEDDEV 2.7/1 is the most Read More
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Absorbable & Non Absorbable Surgical Suture 510k * In general, clinical studies will not be needed for most surgical suture Read More