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In today’s fast-paced, digital-first world, the allure of electronic Quality Management Systems (eQMS) is undeniable.
Challenge: Approach: AlvaMed implemented the following approach: Results: AlvaMed delivered the following: Impact: Project is
The U.S. Food and Drug Administration (FDA) is focused on preventing and mitigating medical device
An eQMS system, or electronic Quality Management System, is a software solution designed to automate
Background and Challenge: A medical device manufacturer sought FDA clearance for its innovative lidocaine delivery
FDA recently issued a draft guidance document on “Protocol Deviations for Clinical Investigations of Drugs,
On January 7, 2025, the FDA issued a draft guidance document on “Evaluation of Sex-Specific
Challenge: A small company specializing in an innovative robotic platform technology for precision surgery in
In an era where medical devices and pharmaceuticals are becoming increasingly complex, ensuring their safety
