eQMS 2

AI-powered software for medical device certification and compliance in the EU and US. Formly is an AI-powered software designed to simplify and expedite the medical device certification process, particularly for startups. It offers tools for creating and managing required documentation, expert regulatory guidance, and AI-backed documentation writing to help companies achieve EU and US medical device compliance and get to market quickly and on budget. Formly supports various standards including MDR 2017/745, US FDA 21 CFR, ISO 13485, ISO 14971, IEC 62304, and IEC 62366.

Enzyme QMS is a quality management system software for life sciences companies. Enzyme QMS software includes modules for all stages of the product development life cycle from Design Control to CAPA. Their in-house experts are available to guide users through quality challenges and the regulatory submission process. Enzyme QMS software covers the key components of cGMP, the QSR, and ISO standards, and all stages of the product development lifecycle. It is 21 CFR Part 11 compliant, validated out-of-box, and offers an industry-leading number of integrations. Designed to scale as companies scale, Enzyme supports the full product lifecycle, serving medical device, digital health, and biopharma companies. Enzyme QMS has everything needed from premarket to postmarket, startup to IPO, and adapts to the user's way of working.