ENZYME BLOGAnalyzing the latest developments in regulatory, compliance, and quality

By Shawn M. Schmitt Communications Specialist, Enzyme When longtime MedTech industry expert Elisabeth George learned in recent years that a medical device manufacturer was using DEHP in products bound for the US market, she immediately knew that someone dropped the proverbial regulatory ball. DEHP – di-(2-ethylhexyl) phthalate – is a potentially cancer-causing chemical, the use...

By Shawn M. Schmitt Communications Specialist, Enzyme Those who play in the MedTech industry have undoubtedly heard the term Cost of Poor Quality, which, in the simplest of explanations, affixes a price for when a manufacturer makes subpar products and/or operates a problematic quality system. A quick Google search for “Cost of Poor Quality” returns...