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. Coupled… 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. In keeping with industry trends, a major factor cited for… Read More
