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.

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what's new

  • JACRI FDA SPEECHES

    Ken Block was invited to give two speeches to Japan Association of Clinical Reagents Industries (JACRI) members in Tokyo on November 28. He discussed FDA topics including new 510(k) guidance documents and new QMSR. The event had over 100 attendees! This presentation marked almost exactly 14 years since his first JACRI speech as their invited FDA expert.

  • FDA HQ VISIT

    Ken Block is fresh off a successful meeting with the FDA at their headquarters, with a client from Japan. Visit our Services pages to learn more about what KBC can do for you!

  • BREAKTHROUGH DEVICE DESIGNATION

    KBC recently achieved our third client Breakthrough Device Designation success.

  • BREAKTHROUGH DEVICE INTERVIEW

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

featured services

  • COMPLIANCE

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

  • 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.