Case Studies

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…

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…

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…

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…

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…

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…