The Partnership Continues: Greenlight Guru to offer RookQS SaMD Templates
What is SaMD? SaMD stands for Software as a medical device. Software as a medical device is any software intended to be used for one or…
QA/RA Implications of the New ‘Predetermined Change Control Plans’ Guidance
CDRH finally issued Draft Guidance on Pre-determined Change Control Plans for AI/ML-enabled medical devices or AI/ML-enabled device software functions, including software functions that are part of…
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…
Understanding the FDA’s Final CDS Guidance
The Final Clinical Decision Support (CDS) Guidance, describes the FDA’s regulatory approach to Clinical Decision Support (CDS) software functions. Suffice it to say that much of…
MedTech Software Verification and Validation
Over the past decade, interest in innovating and commercializing medical devices has significantly increased. In the current trend of MedTech, Software as a Medical Device (SaMD)…
Challenges of SaMD (Software as a Medical Device) Product Development
The trend of the software industry has been evolving throughout the years. In the past, projects were mainly about digitalization, rule based automation, and local server…
Software as a Medical Device (SaMD) Audit Challenges
Software as a Medical Device (SaMD) is no longer an emerging vocabulary in 2022. With the rapid development of medical digitalization, medical devices are no longer…
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…
Align Agile Practices with QMS Requirements
By Allen Chen, Senior Quality Engineer at Rook Quality Systems Taiwan Branch Agile is a practical framework and an iterative approach for product development and project…