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By Hemadri Doma, Tolmar Inc. | In 2022, the FDA released a draft guidance on computer software assurance that promises to reshape the validation of automated data processing system and quality system software in the pharma/medical device industry and to enhance the quality, availability, and safety of medical devices. This article walks through the key elements of the guidance. |
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By Shalini Nagar, Research Nester | Autoinjectors offer a dependable method for delivering medication, especially during emergency scenarios. This article shares new market research, including macro trends, smart features, disposable vs. reusable trends, and more. |
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By Renée Bailey, BlackHägen Design | How can companies keep pace with the demand in the combination products market while meeting or exceeding regulatory expectations of applying human factors engineering? This article provides an overview. |
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| Why Biological Indicators Survive A Validated Cycle | White Paper | By Garrett Krushefski, Mesa Laboratories | We review what to do should you ever find yourself in the situation where the probes indicate conditions that would render killed BIs, yet the units are testing positive. |
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