The Medpoint Blog

Learn best practices and gain new insights on quality assurance, regulatory strategy, and clinical affairs.

The Largest Medical Device Market in the World: Do You Need Help?

The United States of America is the largest medical device market in the world. A population’s age is a good indicator of how high the need for medical devices will be in the coming years. As the United States’ “Baby Boom” population(those born in the years 1946-1964) continues to age, the medical market is projected to steadily increase.  Read More

A Lesson in the Importance of Premarket Approval

Recently, the FDA ordered that all sales and distribution ofsurgical mesh for transvaginal repairs be stopped. Both companies still sellingthe mesh have 10 days to submit plans to remove the mesh from the market. Theruling is the latest in a series of FDA actions targeting the escalating safetyrisks associated with the mesh. The FDA’s order garnered mass attention nationwidein large part because... Read More

FDA Announces Changes to 510(k) Process

The last several years have brought many changes to the medical device quality and regulatory industries, and recent FDA announcements promise even more in the near future. As announced in late November 2018, there are significant updates planned for the 510(k) submission process, specifically related to the use of predicates.  Read More