Formly provides a comprehensive solution for startups to achieve medical device certification compliance in the EU and US markets. By leveraging AI technology and a team of experienced regulatory experts, the platform simplifies the documentation process required for ISO 13485 compliance, technical documentation, and change management. Formly ensures that companies can scale according to their needs and stay updated with compliance alerts, automating tedious documentation tasks. Suitable for various device classes, it accelerates the go-to-market process, ensuring that all regulatory standards including MDR 2017/745 and US FDA 21 CFR are met.

MVP Studio is a tech startup incubator and product development company focused on crafting human-centered mobile applications. The company utilizes a Minimum Viable Product (MVP) approach, providing rapid innovation and strategic product development. They offer a cradle-to-launch service ensuring concepts are turned into tangible, market-ready products, allowing businesses to focus on other critical aspects while the product reaches market readiness.