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By Marcelo Trevino, independent expert | The U.K.’s MHRA has updated its transition arrangement dates for CE marked devices with regard to EU MDR compliance. |
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By Erika L. Roberts, ELR Lab Services LLC | The FDA recently announced that they have seen an increase in the number of entities that contract out testing or services where the data provided by said firms was fabricated, duplicated, or just deemed “unreliable.” Here's what you can do. |
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By Jayet Moon and Arun Mathew | The transition to a Quality Management System Regulation (QMSR) has effectively superseded the explicit medical device design controls CFRs and associated FDA guidance, though their essence lives on. |
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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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| Bridging Human Expertise And AI: The Future Is Here | Q&A | An Interview with Justin Sanchez, Ph.D., Battelle | Discover how leveraging AI's capabilities while relying on human expertise can optimize human performance in the healthcare sector and pave the way for a more efficient, effective healthcare system. |
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