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...
Michelle will review submissions for Enzyme clients and consult with them on regulatory strategy as well as provide valuable input on Enzyme’s product roadmap. She has authored and led numerous premarket submissions and regulatory strategies for Class I-III devices.
Electronic Quality Management System
Enzyme eQMS is flexible and scalable, making it easy to use for startups, yet configurable to meet the needs of the most complex enterprise
