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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