Last week, the U.S. Food and Drug Administration (FDA) released three new draft guidances to strengthen the 510(k) program and to advance the safety and effectiveness…
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…
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…
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…
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…
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…
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…
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…
CDRH finally issued Draft Guidance on Pre-determined Change Control Plans for AI/ML-enabled medical devices or AI/ML-enabled device software functions, including software functions that are part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…
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…