In order to market a medical device in America, a manufacturer will need to gain FDA approval, which starts with submitting an FDA 510(k) Pre-Market Notification. This is used to show the medical devices safety for use, and the details must include the similarities and differences to devices that already exist.
We can work with you and our subsidiary company to help compile your FDA 510(k) submission, including technical documentation review and identifying the relevant testing standards.
Get in touch with our team to discuss your medical device requirements for the American market
Visit the Cranage EMC Testing Limited website for more information on FDA 510(k)