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Medical Device Software (MDSW) is a growing, fast-evolving industry. However, manufacturers must often face a regulatory framework which does not evolve at the same speed. Regulation for medical devices is restrictive, since it needs to guarantee...
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On January 9, the United Kingdom (UK)’s Medicines and Healthcare Products Regulatory Agency (MHRA) released a regulatory framework – Roadmap towards...
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What is a rescue study? A rescue study is a clinical trial that is being conducted by a new vendor after having previously been conducted by another...
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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)...
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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...
