Regulatory Compliance for the Rest of Us
QMS, MDR, CAPA, NC, ISO 13485, 21CFR820, 510(k), PMA. Navigating the world of regulatory compliance is not only a game of alphabet soup, it's also an ongoing challenge.
If you're a founder of a medical device or diagnostic company and wondering 'how does anyone make sense of this', you're not alone.
At Enzyme, we're building software that helps companies gain and maintain their compliance without burying them in a ton of paper forms or charging six-figure consulting fees
Our first product is a quality management system (QMS) tailor-made for medical device companies