5 BOLD Predictions for Medical Device Quality in 2023
With the new year upon us, we asked our Founder/President, Kyle Rose, and our General Manager (Taiwan Branch), Andrew Wu, to peer into their respective crystal…
APAC (Asia-Pacific) Medical Device Regulatory Landscape
The medical device market in the Asia-Pacific region has been growing year by year, with a 6.8% CAGR [1] due to an increase in the number…
AI Product in Healthcare – Andrew Wu
Agenda: Applications of AI in Medicine & Healthcare. Risk of using AI in Healthcare from a stakeholder’s point of view. Risk of approving AI in…
Best Practices For a SaMD MDR Application
Software as a medical device (SaMD) is a rapidly evolving field, posing opportunities and challenges for device organizations and regulators. We would like to dedicate this…
Peace of Mind At Your Fingertips: Digital Health Funding Explodes
To say that the Covid-19 pandemic has changed our lives is a major understatement. Since the outbreak, we’ve all experienced fear, anxiety and some form of…
New FDA Guidance Regarding Bench Testing
The FDA has recently posted new guidance regarding bench testing. FDA suggests including both test report summaries and complete test reports, when appropriate. Complete test reports…
Five action items to address Artificial Intelligence/Machine Learning- based SaMD
The FDA recently released an Action Plan to address Artificial Intelligence/Machine Learning (AI/ML)-based Software as a Medical Device (SaMD). The action plan is based on efforts…
FDA Digital Health Center of Excellence Listening Sessions
The two sessions were moderated by Bakul Patel | Director for the Digital Health Center of Excellence (DHCoE) On September 22, 2020, the FDA established the…
Software as Medical Device (SaMD) Challenges and Opportunities for 2021 and Beyond Webinar
This webinar was hosted by Andrew Wu, Branch Manager | Software Consultant at Rook Quality Systems. On December 9th, 2020, an online webinar regarding the SaMD…
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…