Blog
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CDRH finally issued Draft Guidance on Pre-determined Change Control Plans for AI/ML-enabled medical devices or AI/ML-enabled device software functions, including software functions that are part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…
Shining A Light on MDR Notified Body Standard Fees
The EU Medical Device Regulations (MDR) has been a looming, dark cloud of change for Medical Device Manufacturers. Whether the discussion is focused on the new…
Internal Audits & Annual Physicals: Is Ignorance Really Bliss?
What Do Your Annual Internal Audit and Annual Physical Have in Common? They both roll around once a year, and both are typically dreaded. Your annual…
Medical Device Cybersecurity
Recommended Practices for Software-Contained Device Manufacturer Why Cybersecurity for Medical Devices? As more medical device software is released to the market, information exchange and integration between…
How to Prepare Human Factors Documentation for the FDA Premarket Submission
When medical devices are user-friendly there is a higher probability for users to continue using the device for clinical or personal purposes and highly recommend the…
When to Start Preparing for the IVDR
What is the IVDR? An Overview The EU IVDR 2017/746 is the European Union In Vitro Diagnostic Regulation. This regulation is replacing the EU IVDD In…
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…
How to Simplify Medical Device Reporting Set-Up
What is a Medical Device Report? Medical Device Reports (MDRs) are publicly accessible documents resulting from an event that manufacturers or importers become aware of and…