Ken Block Consulting
Kenneth L. Block, RAC, is an experienced professional in FDA regulatory services and quality assurance, currently serving as President of Ken Block Consulting since April 2005, providing services such as QSR compliance audits and 510(k) applications, with a focus on the Asian market. Previous roles include Director of Quality and Regulatory at Galt Medical, overseeing regulatory activities for vascular access products, and Quality Engineer at Neuro Resource Group, where implementation of a QSR compliant quality system was key. Kenneth also held positions as Director of Quality Systems and Regulatory Affairs at D4D Technologies, Director of Quality Assurance and Regulatory Affairs at Estill Medical Technologies, and worked as an independent consultant before that. A strong engineering background includes a role as Senior Manufacturing Engineer at Quest Medical, where significant process improvements and product innovations were achieved. Kenneth holds a B.S. in Physics from Rose-Hulman Institute of Technology.
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Ken Block Consulting
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.