Ken Block
Ken Block
Ken Block Consulting

Ken Block is an internationally recognised expert in FDA medical device regulations, speaker at medical device conferences worldwide, acting corporate RA/QA VP for several startup device companies, and founder of an international regulatory and quality consulting company with offices in Dallas and Tokyo metropolitan areas.  

Ken is the founder, owner, and leader of Ken Block Consulting, an FDA regulatory and quality consulting company, whose talented cadre of full-time employees are focused on assisting medical device companies worldwide.

Ken provides FDA and ISO regulatory and quality systems services to medical device companies worldwide, including regulatory strategy for new companies and new devices, creation and submission of 510(k) applications, creation and improvement of company quality systems, assistance regarding FDA inspections, and resolution of 483 and warning letter issues.

Ken has 30 years’ experience in hands-on positions within regulatory affairs, quality systems, quality assurance, quality control, manufacturing engineering, process engineering, design, and validation.

My Sessions
M&A Due Diligence
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Presentation Introducing Stage A20

 


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