On September 13, 2022 the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...

The U.S. Food and Drug Administration (FDA) recently finalized its guidance document, Computer Software Assurance for Production and Quality System Software, for software used in device production and ...

DUBLIN--(BUSINESS WIRE)--The "Verification and Validation - Product, Equipment/Process, Software and QMS" training has been added to ResearchAndMarkets.com's offering. This seminar will provide ...

The computer vision leader offers controlled release cloud-based software to speed up innovation for life-enhancing drugs and medical devices PALO ALTO, Calif., May 2, 2023 /PRNewswire/ -- Landing AI, ...

At The Constellation Forum 2025 in New York, Gottlieb said there are and will continue to be challenges regulating software when it comes to AI devices.

BOSTON--(BUSINESS WIRE)--Sware, provider of the most complete software validation solution for innovative life sciences companies, today announced that it raised $6 million in Series B funding, ...

Market opportunities lie in modernizing software development and validation approaches, emphasizing agility and continuous validation to meet changing needs, while ensuring compliance with FDA ...

Makers of dental equipment don’t typically show up on the U.S. FDA enforcement radar screen, but the introduction of biologics and software into routine dental practice has upped the regulatory stakes ...

(MENAFN- GlobeNewsWire - Nasdaq) The main market opportunities lie in leveraging AI, ML, and LLMs to enhance efficiency and effectiveness in FDA-regulated medical device and SaMD development. These ...

Spectral AI, a developer of the AI-driven DeepView® System for predicting burn healing, announced that national burn care leaders contributed over 511 in-person days to train and validate the system ...

Artificial intelligence (AI) has practically limitless applications in healthcare, ranging from auto-drafting patient messages in MyChart to optimizing organ transplantation and improving tumor ...