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Medical Device QA – Work From Home Tips
Rook Quality Systems has always been a virtual/work from home company utilizing co-working and other tools for our business. With the COVID-19 outbreak, we wanted to…
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/136939/download The FDA recently put out a new enforcement policy for digital health devices treating psychiatric disorders during the COVID-19 Public…
Rook Quality System Announces Taiwan Branch Office
After 8 years of establishment, Rook Quality System has officially launched its first international branch office in Taiwan. The new branch office will open new opportunities…
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…
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…