The Essentials: Regulatory requirements for medical device software
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…
How do startups leverage FDA’s Pre-Cert Working Model – Part 2
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…
How do Startups Leverage FDA’s Pre-Cert Working Model – Part 1
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…
Medical Device Regulation – Getting Started Soon
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…
8 Questions about the European MDR Answered
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…
FDA’s take on Digital Health Regulatory Paradigm Shift
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…
Understanding The New Requirements for QMS Software Validation in ISO 13485:2016
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…