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FDA Releases Updates on Software Guidance
On June 14, 2023, the FDA released their final updated guidance document on the Content of Premarket Submissions for Device Software Functions. The document is the…
From Pandemic to Endemic: What Should Medical Device Manufacturers Do for COVID-19 Transition?
The COVID-19 pandemic has had a significant impact on the medical device industry. During this time, many medical devices became commercially available under enforcement policies, and…
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CDRH finally issued Draft Guidance on Pre-determined Change Control Plans for AI/ML-enabled medical devices or AI/ML-enabled device software functions, including software functions that are part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…