Whether looking to update an existing process or implement something brand new, process design is a critical aspect to...
Programming
Software as a Medical Device
Software-related medical devices are taking over the medical device industry. There are three types of software-related medical devices in the industry software as medical devices, the software is integral to medical devices, and software used in the manufacturer or maintenance of a medical device1. Software that is….
Why Perform a Gap Analysis?
As new technologies continuously push the limits of medical devices and drugs, regulations and governing...
Smartphone-Enabled COVID-19 Test
Becton, Dickinson, and Company, or BD, announced on August 27, that the US Food and Drug Administration (FDA)...
Fiscal Year 2022 Premarket Application User Fees
This past Monday, the FDA announced fiscal year (FY) 2022 medical device user fees. This upcoming fiscal year...
FDA Approves Comirnaty
The day has come where the U.S. Food and Drug Administration finally approves the first COVID-19 vaccination for...
X-Ray Diffraction, a Useful Characterization Technique
X-ray diffraction (XRD) is a non-destructive laboratory technique that assesses the lattice spacing of...
Pharmaceutical Temperature Mapping
Temperature mapping has become increasingly integrated into regular operations for those who produce or handle...
The FDA’s Medical Device Action Plan for Artificial Intelligence and Machine Learning Software
Artificial Intelligence (AI) is the branch of Computer Science that provides the ability for computing systems to...
Nanotechnology in Medical Devices
Nanotechnology is the science of understanding, inventing, and controlling objects which are built in the scales of...
Meeting FDA Regulatory Requirements While Programming PLCs
Programmable Logic Controllers (PLCs) are the components that are used for interfacing between multiple hardware...
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