Welcome to KBC

Serving Medical Device Companies Worldwide

In order to sell a medical device, a company must meet the regulatory requirements of each market where that medical device is to be sold. The purpose of these requirements is to demonstrate that products are safe and effective prior to sale. However, many medical device companies lack sufficient experience or the personnel needed for FDA or other regulatory or standards compliance. Ken Block Consulting offers services at reasonable rates to assist companies in ensuring the production of safe and effective medical devices for U.S. and international markets. Our consulting services cover all areas of FDA regulation that govern those involved in the production and distribution of medical devices.

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featured services


    As technology evolves, regulations evolve. We help your business find its way in a tumultuous environment.


    Whether your firm is large or small, new or established, we will guide you into the largest medical device market in the world. 


    FDA inspections have fully resumed. We will get you prepared via on-site and remote support.


    If you have a novel technology that addresses a life-threatening or seriously debilitating disease or condition, we can help you navigate the potential for Breakthrough Device Designation, which fast-tracks the US market introduction along with other advantages.


    If you have a medical device that significantly improves the safety of currently available treatments or diagnostics for a less serious disease or condition, we can help you navigate STeP in order to get your product to the US market faster, among other advantages.