Smith Associates, established in 1985, has been serving the Medical Device industry Worldwide. The company has its roots in medical device marketing, publications concerning medical devices and since 1994 has concentrated on assisting companies large and small in receiving Food and Drug Administration clearance for their new device. E.J. Smith, President, brings 30 years experience in the medical industry from sales to marketing to published author on medical consumables and surgical instruments.
Since 1994 Smith Associates has processed and received clearance for 110 devices, and by the end of 1999 it will have received clearance on over 150 devices. The vast majority of these clearances have been within the Food and Drug Administration timetable for review.
The strengths of our company is the fast turn around time, once we have received the information that Smith Associates will request from your company. We are prolific writers of 510(k)'s and PMA's. We thoroughly research the FDA's information requirements for your device and prepare an easy to use checklist of those requirements for you and your staff to compile. We stay in constant communication with your company during the entire submission process. We prepare the entire submission.
Our staff can also assist those companies that have reached an impasse with the FDA on a current 510(k) or PMA submission. We are located 30 minutes from the Food and Drug Administration and can meet with the FDA on a moment's notice.
Smith Associates also acts as an Official Correspondent and can arrange for U.S. Agent representation in the Washington, D.C. area. Our associate, John Adcock, in England can assist you in obtaining your "CE" mark.
Smith Associates has a complete understanding of the FDA's Current Good Manufacturing Practices (cGMP) and can assist companies in cGMP audits. We have conducted audits worldwide.
We understand the importance of bringing product to market as quickly as possible and holding down the cost of dealing with the FDA.
We are positive that we can be of service if you have 510(k) and PMA needs. We look forward to hearing from you to discuss those needs and the services that Smith Associates can offer your company.
