Medical device equipment manufacturers work in an environment where product quality isn't just a competitive advantage, it's a regulatory necessity with direct implications for patient safety. As ...
Integrating Git version control with validation systems automates medical device software traceability, ensuring instant ...
FDA’s 21 CFR Part 820 — Quality System Regulation (QSR) has not been updated since it was first released in 1996 . . . until now. Are you ready? Part of a panel at the conference discussing the ...
Shashank Murali is a Quality Assurance professional based in Minneapolis, Minnesota, with more than eight years of experience in the medical device technology area.
Drug & Device Team provides recommendations based on Food & Drug Administration (FDA) draft guidance on Quality Management System ...
The U.S. Food and Drug Administration (FDA) issued updated draft guidance, “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions,” which aims to help ...
DUBLIN--(BUSINESS WIRE)--The "How to Write Effective Standard Operating Procedures (SOPs) and Other Process Documents Course (Nov 4th - Nov 6th, 2025)" training has been added to ...
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