• FDA

    SUBMISSIONS

    Total support. From the ground up or just fine-tuning,
    and everything in between.

  • RISK

    MANAGEMENT

    The risk-based approach is more than risk analysis.
    Let us be your guide.

  • VALIDATION

    What does it do? Prove it.
    We can show you how.

  • REGULATORY

    STRATEGY

    Charting an effective course to market
    and planning for the future.

  • REGISTRATION

    AND LISTING / US AGENT

    Registering your facilities, listing your devices
    and corresponding with the FDA.

  • QUALITY

    SYSTEMS

    Putting all the pieces together
    for FDA and ISO compliance.

  • COVID-19

    RESPONSE

    As COVID-19 continues to have a profound impact on our society, we at Ken Block Consulting are taking every precaution to ensure the safety of our employees, clients, and community. 

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

  • 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.