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What To Do (And What Not To Do) When You Receive a FDA Audit Notice
Receiving an audit notice from the FDA can be a daunting experience, but it also presents a great opportunity for your medical device company to demonstrate…
Risk Management in the Medical Device Industry – Part 2
ISO 14971 and ISO 24971: Enhancing the Safety of Medical Devices through Effective Risk Management The development and manufacturing of medical devices are critical processes that…
Risk Management in the Medical Device Industry
Building trust with patients is one of the most important foundation blocks in the medical device industry. Developing patient trust is strictly driven by ensuring that…
Where does AI meet the Medical Device Industry?
Artificial intelligence (AI) is changing the world and the medical device realm, but in reality, it is a simple word: automation. In this blog post, we…
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CDRH finally issued Draft Guidance on Pre-determined Change Control Plans for AI/ML-enabled medical devices or AI/ML-enabled device software functions, including software functions that are part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…