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June 1, 2023
Indianapolis, IN (PRWEB) June 01, 2023 -- Greenlight Guru, the leading provider of cloud-based software for MedTech companies, today announced that it is
March 3, 2023
This article reviews the existing FDA programs impacting artificial intelligence (AI) / machine learning (ML) technologies in medtech, as well as the...
November 16, 2022
The ISPE's latest GAMP 5 guidelines steer validation practices for pharma companies to meet the computerized system expectations.
October 11, 2022
There were so many interesting and significant developments related to the various missions of the U.S. Food and Drug Administration (FDA) during the last week or so of September 2022...
October 11, 2022
There were so many interesting and significant developments related to the various missions of the U.S. Food and Drug Administration (FDA) during the last week or so of September 2022...
October 5, 2022
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and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document...
September 15, 2022
The FDA has issued draft guidance on computer software assurance for computers and automated data processing systems used in medical device production.