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On February 2, 2024, the Food and Drug Administration (FDA) issued a final rule to amend the device current good manufacturing practice (CGMP) requirements of the Quality System Regulation (QSR). The final rule is effective February 2, 2026.
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On 23 January 2024, the EU Commission published a new proposal for amending the regulations EU 2017/745 (MDR) and EU 2017/746 (IVDR) aiming to...
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Why search the scientific and medical literature?
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The human factors team at Veranex has reviewed the NMPA Guidance Draft 01 and Draft 02 and submitted feedback to the agency. We’re committed to...
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Introduction Nanomaterials, tiny scientific wonders that are invisible to the naked eye, hold the potential to revolutionize numerous facets of our...
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What are some of the challenges with database builds for medical device studies, given the current regulatory requirements? What are the important...
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The landscape of modern healthcare has been completely transformed by the development of cutting-edge medical devices. From life-saving implants to...
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The 19th Precision in Clinical Trials (PCT) Summit – Amsterdam brought together a wide range of representatives from the life sciences industry, from...
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Susanah and Tucker, A Mother-Son Duo In 2016, Susannah Ashcroft drove home from an appointment at St. David’s Center for Child and Family Development...
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Vigilance reporting and postmarket surveillance of medical devices are among the many requirements documented in the EU MDR (2017/745) to ensure the...
