CEO & Co-Founder at FormlyAI | Medtech certification for startups made easy | ex-FDA
A technical file is a document that contains a comprehensive overview of information and documentation showing a medical device meets the requirements listed in the European Union’s Medical Device Regulation (MDR) 2017/745. The technical file serves as a record of the device's development, including its design
Who is Formly AI? Formly is a group of “regulonauts” (We made up a word, so what?) daring to go where no-one has gone before! Our small team has a dream of making medical device conformity easy for everyone, whether this is your first medical device or your 100th. We
What is a QMS? A quality management system (QMS) is required for most medical devices. A QMS is a set of processes and procedures that ensure that medical devices are consistently designed, developed, manufactured, and distributed in compliance with applicable regulatory requirements and standards, while also meeting the needs of
You may be wondering whether or not you should pursue putting your medical device on the market in Europe or the United states first. While it is understood that the United States and Europe are two of the largest medical device markets, their regulatory requirements differ. In this blog we
