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Tag: Medical Devices

Last Updated on June 15, 2023
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Posted in BLOG, FDA Updates
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Leave a Comment on New Updated 2023 FDA Final Guidance Significantly Changing Premarket Submissions Requirements for Medical Device Software

By - SebastianFeye

New Updated 2023 FDA Final Guidance Significantly Changing Premarket Submissions Requirements for Medical Device Software

Medical Device software continues to evolve and change as do FDA regulations. When it comes to the content of the software documentation requirements for a pre-market submission (510k), the FDA’s last issued guidance back in 2005. However, on June 14 2023, FDA released a new and revised final guidance document which substantially alters software requirements for 510k submissions by changing

Tagged : 510(k), 510k, FDA, Guidance, Medical Devices, SAMD, Software, Specifications, SRS

Last Updated on May 20, 2021
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Posted in BLOG, FDA Updates
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Leave a Comment on Artificial Intelligence and Machine Learning Workflow Driving Innovative Medical Device Development

By - SebastianFeye

Artificial Intelligence and Machine Learning Workflow Driving Innovative Medical Device Development

In 2011, Marc Andreessen, a venture capitalist, stated “Software is Eating the World”. Ten years later, software development has accelerated and expanded industries that could not have been imagined a decade ago. Automated medical devices are central to this phenomenon and complex software programs with increasingly advanced algorithms are designed to operate with hardware in order to fulfill its intended

Tagged : 510(k), Artificial Intelligence, FDA, Improvement, Lifecycle, Machine Learning, Medical Devices, Product, Regulatory, SAMD, Software, Specifications, Total, TPLC, Transparency