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…
Key Considerations for SaMD Companies Developing and Commercializing Software as Medical Devices
This webinar was hosted by Andrew Wu, Branch Manager | Software Consultant at Rook Quality Systems. You will find this webinar helpful for understanding how Rook…
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…
Implementing Changes to SaMD under new EU MDR
Hosted by Andrew Wu of Rook Quality Systems, this podcast will help you understand changes imposed on SaMD under new EU MDR. SaMD manufacturers will benefit…
What is Software as a Medical Device (SaMD)?
This post was published by Jon Speer, the Founder and VP QA/RA at Greenlight Guru. Medical devices are a big business covering a wide range of…
Classification and Qualification of SaMD under MDR
Currently, we are witnessing a drastic regulatory shift as MDR (2017/745/EU) replaces MDD (93/42/EEC) and AIMDD (90/385/EEC), effective May 26th, 2020. As a result, some Software…
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…