Drug & Device Team provides recommendations based on Food & Drug Administration (FDA) draft guidance on Quality Management System ...
Study reveals a gap FDA approval AI radiology devices with only 29% undergoing clinical testing before clearance.
Integrating Git version control with validation systems automates medical device software traceability, ensuring instant ...
FDA Section 524B transformed medical device cybersecurity from guidance to law, challenging small medtech firms with ...
Beyond Tariffs: The Software Supply Chain Risks Every Medical Device Manufacturer Should Be Watching
By reframing security as an investment rather than a cost, MDMs can reduce risk exposure, improve compliance readiness, and ...
CROWN POINT — A five-year tug-of-war to determine who controls Lake County's purchasing power officially is over.
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