FDA uses a range of biocompatibility test data to evaluate medical devices before clearing or approving them for marketing. The growing use of FDA-recognized consensus standards facilitates this ...

Medical device manufacturers use cytotoxicity testing to help prove that devices that come into contact with the human body are biocompatible. Testing results are critical for gaining market access, ...

Stability studies measure how medical devices respond to environmental stresses such as temperature, humidity, light, and ...

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In this interview, Instron's Landon Goldfarb discusses the importance of mechanical testing for medical devices used in diabetes care and treatment. How has the treatment of diabetes changed over the ...

Medical device design and development has evolved over the years, notably influenced by market demands and regulatory requirements. Traditional design practices, beginning with a reliance on generic ...