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By Marcelo Trevino
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The FDA has now completed just over 100 inspections under its new Quality Management System Regulation, and the agency has begun sharing preliminary observations from those inspections.
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By Kamila A. Novak, KAN Consulting
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Kamila Novak reviews final computer software assurance (CSA) guidance and what it means for those working on medical device clinical trials.
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By Hiep X. Nguyen, DPharm, Ph.D., DTM, California Northstate University
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Let's take a closer look at the scientific principles, technological progress, and translational hurdles defining the present state of microneedle research.
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The Hidden Costs Of Multiple-Vendor Contract Manufacturing
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Article | Pharma & MedTech Partner Division, B. Braun Medical Inc.
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When it comes to outsourcing in medical device manufacturing, this article discusses these consequences and presents the advantages of working with a single-source contract manufacturer.
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