Software Development Process for Healthcare Applications
Summary of Key Points Software development process require a variety of process planning activities that would address how you design, implement, and maintain software throughout its…
Documentation impacted by EU MDR
For medical device companies selling in the EU, the May 2020 deadline for Europe’s new Medical Device Regulation 2017/745 (MDR) is coming up soon. Post this…
Enforcement Policy from the FDA to combat COVID-19
Link to the Policy Document: https://www.fda.gov/media/136290/download As the COVID-19 situation is getting more serious all over the world, FDA issued an enforcement policy for non-invasive remote…
Enforcement Policy — Digital Health Devices For Treating Psychiatric Disorders During COVID-19
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…
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…