October 2023 Recent medical device news highlights related to Class III implantable medical devices in the areas of cardiac rhythm management and diabetes treatment. Always ensure to follow up on the provided links for detailed information. I found MITs implantable device with pancreatic islet cells and an oxygen factory fascinating and scary. I would haveContinue reading “MedTech News”
Tag Archives: MedicalDeviceManufacturing
Understanding the FDA’s PCCP for Software Changes
In the rapidly evolving world of medical technology, the ability to swiftly and efficiently update software is crucial. The FDAs innovative Predetermined Change Control Plan (PCCP) approach is set to revolutionize the process of making post-market software modifications to medical devices, particularly those incorporating artificial intelligence/machine learning (AI/ML) technologies. Traditional Approach vs The PCCP ApproachContinue reading “Understanding the FDA’s PCCP for Software Changes”
Mr. Red Tape’s MedDev Adventures
Unraveling the FDA’s Quality System Regulation (QSR) for Medical Device Manufacturers
The medical device industry is a highly regulated space, with manufacturers having to adhere to numerous guidelines and regulations set forth by regulatory bodies like the U.S. Food and Drug Administration (FDA). One such critical regulation is the Quality System Regulation (QSR) in 21 CFR Part 820, which mandates manufacturers to establish and maintain proceduresContinue reading “Unraveling the FDA’s Quality System Regulation (QSR) for Medical Device Manufacturers”
C. Austin Insight 