In the world of medical devices, software plays a critical role. However, not all software used in these devices is developed from scratch. Often, off-the-shelf software, or software of unknown provenance (SOUP), is integrated into the device. But what exactly is SOUP? Update: We also released a new
Can I Certify as Class I First and Do Class IIA Later? We have had many clients come to us and ask any variety of the same question: “I think my device will end up being Class IIA but I want to start with it on the market as Class
The Difference Between IVDR and MDR in the EU The European Union's regulatory framework for medical devices can be quite perplexing, especially for startups venturing into the healthcare sector for the first (or even 10th) time. Knowing whether your product falls under In Vitro Diagnostic Regulation (IVDR) 2107/
The path to bringing a medical device to the European Union (EU) market is paved with challenges, chief among them being successfully acquiring a CE mark. The CE mark certification is a passport for your medical device, allowing it to be sold across all EU countries. The CE mark for
The European Union (EU) medical device market is a labyrinth of regulations that can baffle even the most seasoned medical device makers. If you find yourself pondering, "Does my product even qualify as a medical device?" you're not alone. This quick guide is designed to detangle
Calling all Medtech innovators, Do confusing requirements for your medical device's CE mark have you scratching your head? Don't want to spend a year and pay an arm and a leg to get certified? You've come to the right place. For a limited time
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.
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
