MTI roundup of global medical device regulatory news EU Commission Updates EU MDCG 2025-10 Guidance on Post-Market Surveillance (2025) The EU MDCG 2025-10 Guidance on Post-Market Surveillance of Medical Devices…
MTI roundup of global medical device regulatory news EU Commission Updates EU MDCG 2025-10 Guidance on Post-Market Surveillance (2025) The EU MDCG 2025-10 Guidance on Post-Market Surveillance of Medical Devices…
…Speech at RAPS Annual Conference. Regulatory Affairs Professionals Society. Link: https://www.raps.org/news-and-articles/news-articles/2023/3/makary-calls-for-regulatory-harmonization-at-raps-2023 [5] U.S. Food and Drug Administration. (1978). Quality System Regulation. Link: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820 [6] IMDRF. (2024). Harmonization Cost Analysis. Link:…
…Speech at RAPS Annual Conference. Regulatory Affairs Professionals Society. Link: https://www.raps.org/news-and-articles/news-articles/2023/3/makary-calls-for-regulatory-harmonization-at-raps-2023 [5] U.S. Food and Drug Administration. (1978). Quality System Regulation. Link: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820 [6] IMDRF. (2024). Harmonization Cost Analysis. Link:…
…Centers (PSCs) nationwide. The FDA-cleared test builds on and replaces a similar pTau-217/Beta Amyloid 42 Ratio test that the company launched in April 2025. View original content to download multimedia:https://www.prnewswire.com/news-releases/labcorp-launches-first-fda-cleared-blood-test-for-alzheimers-disease-302531885.html…
…Centers (PSCs) nationwide. The FDA-cleared test builds on and replaces a similar pTau-217/Beta Amyloid 42 Ratio test that the company launched in April 2025. View original content to download multimedia:https://www.prnewswire.com/news-releases/labcorp-launches-first-fda-cleared-blood-test-for-alzheimers-disease-302531885.html…
The Associated Press reported barely a week after mass firings at the Food and Drug Administration, some probationary staffers received unexpected news over the weekend: The government wants them back….
The Associated Press reported barely a week after mass firings at the Food and Drug Administration, some probationary staffers received unexpected news over the weekend: The government wants them back….
…emails on Saturday evening that their jobs were being eliminated. CBS News obtained a letter that outlined the reasons that staff at the Department of Health and Human Services (HHS)…
…emails on Saturday evening that their jobs were being eliminated. CBS News obtained a letter that outlined the reasons that staff at the Department of Health and Human Services (HHS)…
…(NHS), for example, will only purchase sustainable medical products from 2030 onwards.[4] [1] https://www.bafa.de/DE/Lieferketten/Multilinguales_Angebot/multilinguales_angebot_node.html [2] https://www.uni-wuerzburg.de/aktuelles/einblick/single/news/gruene-endoskopie-am-ukw/ [3] Scope 1: Emissions that arise directly from the company’s activities. Scope 2: Emissions…
…(NHS), for example, will only purchase sustainable medical products from 2030 onwards.[4] [1] https://www.bafa.de/DE/Lieferketten/Multilinguales_Angebot/multilinguales_angebot_node.html [2] https://www.uni-wuerzburg.de/aktuelles/einblick/single/news/gruene-endoskopie-am-ukw/ [3] Scope 1: Emissions that arise directly from the company’s activities. Scope 2: Emissions…
…facilitated. As well as patient demand, regulatory and market forces will determine the pace of change towards greener alternatives. References [i] https://www.whitehouse.gov/briefing-room/statements-releases/2022/06/30/fact-sheet-health-sector-leaders-join-biden-administrations-pledge-to-reduce-greenhouse-gas-emissions-50-by-2030/ [ii] https://www.healthpolicypartnership.com/the-nexus-between-climate-change-and-healthcare/ [iii] https://www.whitehouse.gov/briefing-room/statements-releases/2022/06/30/fact-sheet-health-sector-leaders-join-biden-administrations-pledge-to-reduce-greenhouse-gas-emissions-50-by-2030/ [iv] https://www.europeanpharmaceuticalreview.com/news/190992/could-plastic-alternative-support-environmentally-sustainable-drug-delivery/ [v] https://www.sciencedirect.com/science/article/pii/S2542504821000348…
…facilitated. As well as patient demand, regulatory and market forces will determine the pace of change towards greener alternatives. References [i] https://www.whitehouse.gov/briefing-room/statements-releases/2022/06/30/fact-sheet-health-sector-leaders-join-biden-administrations-pledge-to-reduce-greenhouse-gas-emissions-50-by-2030/ [ii] https://www.healthpolicypartnership.com/the-nexus-between-climate-change-and-healthcare/ [iii] https://www.whitehouse.gov/briefing-room/statements-releases/2022/06/30/fact-sheet-health-sector-leaders-join-biden-administrations-pledge-to-reduce-greenhouse-gas-emissions-50-by-2030/ [iv] https://www.europeanpharmaceuticalreview.com/news/190992/could-plastic-alternative-support-environmentally-sustainable-drug-delivery/ [v] https://www.sciencedirect.com/science/article/pii/S2542504821000348…
…Surprise Expenses in Medical Bills, Study Finds.” com, CBS News, Aug. 2024, www.cbsnews.com/news/medical-bills-denied-coverage-health-insurance-commonwealth-fund/. Lindner, Jannik. “Study Reveals Shocking Medical Billing Errors Statistics Impacting Americans.” org, 17 July 2024, gitnux.org/medical-billing-errors-statistics/. EU…
…Surprise Expenses in Medical Bills, Study Finds.” com, CBS News, Aug. 2024, www.cbsnews.com/news/medical-bills-denied-coverage-health-insurance-commonwealth-fund/. Lindner, Jannik. “Study Reveals Shocking Medical Billing Errors Statistics Impacting Americans.” org, 17 July 2024, gitnux.org/medical-billing-errors-statistics/. EU…
…Quality Engineering enablers Whilst there are specific challenges to Quality Engineering AI, and nuances to be accounted for, it’s not all bad news. Professionals around the world are working hard…
…Quality Engineering enablers Whilst there are specific challenges to Quality Engineering AI, and nuances to be accounted for, it’s not all bad news. Professionals around the world are working hard…
