White Papers

Integrating Quality by Design (QbD) in Medical Device Manufacturing - Concept, Benefits, and Challenges

Mon, 08/01/2011 - 7:15am
Igor Veljanovski


The medical devices industry, as well as the pharmaceuticalindustry, is slowly but indisputably accepting the concept of Quality by Designinto its design and development product phases, and is introducing thestatistical tools and methods of the concept into its process verification andvalidation phases as well. The Quality by Design concept or approach has foundits implementation in the medical devices life cycle management, under theguidance of risk regulations by the International Conference on Harmonization.Since the importance of successful implementation of this concept is ever moreevident in industry, this white paper will therefore discuss the concept andits possible implementation in the medical devices industry, along with thebenefits and concerns expressed by the manufacturers.


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