Case Studies
PARTNER CASE STUDY
VoCare
VoCare™, a specification developer and distributor of a prescription-use vital monitor called the VoCare Vitals V360, has been on the market since August 2021…
PARTNER CASE STUDY
Sotera Wireless Inc.
Sotera Wireless, Inc. is a San Diego based company dedicated to developing a new generation of early detection surveillance monitoring systems…
PARTNER CASE STUDY
Aptitude Medical Systems
Aptitude Medical Systems is a startup healthcare company specializing in deep-tech. The company has approached Rook Quality Systems to complete the design transfer process…
PARTNER CASE STUDY
Hura Imaging
In 2019, Hura Imaging approached RookQS with the goal of developing and commercializing a software as a medical device in the US. Dr. Danny Wang, from the University of South California, invented a novel denoising algorithm on CT perfusion images…
PARTNER CASE STUDY
Reveri Health
San Francisco-based digital health start-up Reveri Health reached out to Rook Quality Systems to discuss the regulatory implications of their self-hypnosis mobile app, intended for commercialization in the United States…
PARTNER CASE STUDY
Medical Software Development in Agile
A Boston Consulting Group-backed venture reached out to RookQS in 2017 to discuss the need to optimize their Agile process to satisfy the regulatory requirements for commercializing their software as a medical device in the United States…
PARTNER CASE STUDY
Big Health
A San-Francisco based and internationally operating App Developer, Big Health, reached out to Rook Quality Systems in 2020 to discuss assistance with their software development processes in order to satisfy ISO and regulatory requirements for commercializing their software as a medical device in the United States, United Kingdom, and the EU…
PARTNER CASE STUDY
Circadia Technologies
In 2019, Circadia Technologies was pursuing FDA 510(k) clearance for the C100 System, which consists of a contactless breathing monitor for respiratory rate data measurement, mobile application for specific monitor configuration and data review, and a cloud service for clinical staff review of patients’ respiratory data…
PARTNER CASE STUDY
Yunu Medical Imaging
In 2022, Yunu approached RookQS with the goal of achieving 21 CFR Part 11 compliance for electronic records and signatures within their medical imaging platform used for research purposes…
PARTNER CASE STUDY
Neosoma: 510(k) Clearance for AI / ML Devices
Rook Quality Systems has helped numerous clients get through various regulatory submissions with several classes and types of medical devices. Over the last few years…