Published Articles

For many years, numerous professional organizations and publications within the medical device industry (both print and online) have reached out to Ken Block Consulting (KBC), requesting interesting content for their target audiences. In response, we have authored over 20 original articles across a broad spectrum of topics, from software validation and FDA submissions to usability and regulatory due diligence. Readers are typically regulatory and quality professionals, medtech executives, engineers and others. Internationally recognized for our regulatory and quality expertise (and consistent with our office locations in the US, Asia and Europe), original KBC industry articles have been published around the globe in the English, Japanese and French languages. Unlike "pay to play" publications (where articles by other consultants may appear), KBC content has always been invited by the relevant editorial management, with compensation never paid by KBC or received by KBC. Some of these invited articles are shown on this page, including any links to any content available online.