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By Yadnyesh Patel, microbiology subject matter expert | All injectable drug products and implantable medical devices that come into contact with the bloodstream or spinal fluid are tested for endotoxins. This article provides an overview of bacterial endotoxin testing and the LAL method. |
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By Jessica Chen and Thuha Tran, San Jose University | This article delves in what is considered an adaptive AI-driven medical device and the current FDA regulatory considerations for them. |
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By Timothy Bubb, IMed Consultancy | As AI medical devices continue to evolve, collaborating with regulatory experts and embracing multidisciplinary approaches are crucial for navigating challenges and ensuring regulatory compliance. |
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| Design Verification Testing Of Combination Products | Article | By Mike Ulman, West Pharmaceutical Services, Inc. | Developing a combination product and seeking a list of tests to complete design verification testing? Review the details for planning, design inputs, design outputs, and design verification. |
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| The Impact Of PFAS Regulations On Drug Delivery Devices | Article | By Shalene Thomas, Battelle | By adopting a strategic approach and embracing necessary measures, the medical device industry can transform regulatory challenges surrounding PFAS into opportunities for innovation and growth. |
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