Section 510(k) of the Food, Drug, and Cosmetic Act from the Food & Drug Administration (FDA) requires device manufacturers to notify the FDA of their intent to market a medical device.

Medical device companies continually seek ways to reduce costs and increase efficiency in the manufacture of their products. Offshore Medical Device Manufacturing has gained momentum among many companies as a strategy that contributes to the bottom line.

Implementing a CAPA system (Corrective and Preventive Action) is required by the FDA for Medical Device Manufacturing companies selling equipment in the U.S. Despite the alterations and expense required, manufacturers now appreciate how CAPA has increased product reliability.

Over the years LSO has worked with numerous start-ups – visionaries with innovative products and good business sense, but lacking knowledge on the intense amount of regulatory policies and procedures involved in manufacturing and getting a med device to market.

In February, LSO participated, for the 17th consecutive year in the MD&M West show at the Anaheim Convention center. This year, Barry Kazemi, LSO’s CEO & President, had been invited to be one of the panelists.

Medical device contract manufacturing is the outsourced fabrication of a medical device for the medical marketplace.