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 US and international markets. Our consulting services cover all areas of FDA regulation that govern those involved in the production and distribution of medical devices.

what's new

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  BREAKTHROUGH DEVICE DESIGNATION

  KBC recently achieved our third client Breakthrough Device Designation success.

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  BREAKTHROUGH DEVICE INTERVIEW

  Ken Block recently gave an interview with Medtech Insight regarding the FDA's Breakthrough Device Program.

featured services

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  COMPLIANCE

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

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  US MARKET ENTRY

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