Drug & Device Team provides recommendations based on Food & Drug Administration (FDA) draft guidance on Quality Management System ...
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and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...
Integrating a Secure Product Development Framework into the product development lifecycle can help ensure security from the ...
The "The US FDA QMSR Transition - 21 CFR 820 and ISO 13485" training has been added to ResearchAndMarkets.com's offering. The US FDA, after years of discussing the harmonization of 21 CFR 820, Device ...
Dublin, Sept. 22, 2025 (GLOBE NEWSWIRE) -- The "US FDA Medical Device Quality System (QSR) Compliance: Design Controls, Verification & Validation (Oct 27th - Oct 28th, 2025)" training has been added ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results
Feedback