Author Archives: C. Austin

Revolutionizing Medical Device Software: A Look at the New FDA Guidance

On June 14, 2023 the U.S. Food and Drug Administration (FDA) finalized a new guidance document (Content of Premarket Submissions for Device Software Functions) that could be the shift in policy that marks a significant step towards modernizing and streamlining the regulatory process for medical device software, potentially leading to faster innovation and improved patientContinue reading “Revolutionizing Medical Device Software: A Look at the New FDA Guidance”

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”

What makes GPT?

The key GPT (Generative Pretrained Transformer) concepts start with Transformer Architecture, Large Scale Language Models, and Fine-tuning. Transformer Architecture The Transformer architecture is a type of model architecture used in natural language processing tasks. It was introduced in the paper “Attention is All You Need” by Vaswani et al (https://arxiv.org/abs/1706.03762). The key innovation of theContinue reading “What makes GPT?”

Alan Turing

The amazing and tragic life of Alan Turing. Alan Turing was a remarkable British mathematician, logician, and computer scientist. He was born on June 23, 1912, and is widely considered one of the pioneers of modern computer science and artificial intelligence. During World War II, Turing played a crucial role in the British code-breaking effortsContinue reading “Alan Turing”