Link to the Policy Document: https://www.fda.gov/media/136290/download The FDA recently put out a new enforcement policy for digital health devices treating psychiatric disorders during the COVID-19 Public…
Summary of Key Point The key to address medical device software regulation starts with three questions: What does your software do? How do you plan to…
This is Part 2 of a two-part series focusing on FDA’s Pre-Cert Working model. 4. Streamlined Review: It is expected that software products that are considered…
The Pre-Cert program represents a new regulatory paradigm for FDA regulating future software as medical device (SaMD). To cope with shorter development cycles and unique opportunities…
If you are currently selling or are looking to sell a medical device in Europe, you should have heard about the big industry news: the European…
This post was published by Jon Speer, the Founder and VP QA/RA at Greenlight Guru. The European Medical Device Regulation (MDR) is a new set of regulations that…
In recent years, the medical device industry has become overwhelmingly impacted by digital health. According to the US Food and Drug Administration (FDA), products that fall…
As I am sure many of you know, the ISO 13485 standard was updated in 2016, which means the time to transition your Quality Management System…