Smith Associates, established in 1985, has been serving the Medical Device industry worldwide in medical device marketing and publications concerning medical devices. Since 1994, under the direction of E J Smith, President, Smith Associates has specialized in regulatory services for the medical manufacturers of medical devices, in vitro diagnostics, biologics and blood, and cosmetics. Smith Associates has extensive experience in all aspect of the regulatory processes of 510(k)s, IDEs and PMAs. With cleared 510(k)s now numbering well over 200, several PMA and IDEs, we have worked with every reviewing branch of CDRH and CBER.
Smith Associates has assisted many medical companies, large and small, in resolving various compliance issues, including Quality System design (cGMP) and implementation, pre-FDA audits and as a sponsor representative for FDA Class III audits. Compliance issues have also included warning letter responses, labeling review for devices and cosmetics, and clinical trial administration plans.
As President of Smith Associates, Mr. E J Smith brings 43 years of experience in the medical industry in marketing and executive positions and as the author of two definitive books on medical devices : Hospital Consumables, Prentice-Hall and Smiths Reference and Illustrated Guide to Surgical Instruments, JB Lippincott
We understand the importance of bringing your product to market as quickly as possible and also cost effectively dealing with all of the compliance regulations of the FDA. We look forward to hearing from you to discuss those needs and the services that Smith Associates can offer your company.
