ST&R can assist you with your medical devices by providing the following services:
- preparation of a pre-market applications (510(k) for your medical device
- determination of appropriate device classification (class I, II, or III) or existence of exemption status
- identification of predicate devices for substantial equivalence determination
- support in developing Federal Trade Commission-compliant advertising materials (print and Internet)
- counseling clients on good manufacturing practices, labeling and advertising matters, conducting product recalls, responding to warning letters and managing FDA inspections
Additional information regarding importation of your medical device can be found at our Import and Export of FDA-regulated Products page.
If you require assistance with your medical device, please contact Edgar J. Asebey-Birkholm at
easebey@strtrade.com or at (305) 913-3902.