Most 510(k) submissions will include some type of performance data. The extent of performance data will depend on the complexity Read More

Section 513(g) of the FDA One of the difficulties that medical device manufacturers encounter is deciding how to proceed with Read More

Biocompatibility Assessment Device biocompatibility is the ability of a medical device or material to perform with an appropriate host response in Read More

  The following are the information requested by MHRA Registration of Medical Devices. Manufacturer (Facility) Information: Legal manufacturer Name, Address Read More

Process to Rule out Level of Concern of Software Medical devices for 510(k) Submission Software Level of Concern (LOC) relates Read More

FDA Registration for New Drug is mandatory if you want to sell OTC and over the counter drug products in Read More

This blog post has been created for those who want to learn about the importance of CE Marking. We used Read More

All the scientific articles are gathered together as a primary part of the clinical evaluation. MEDDEV 2.7/1 is the most Read More

Absorbable & Non Absorbable Surgical Suture 510k * In general, clinical studies will not be needed for most surgical suture Read More