Search Results for: “EU MDR”

post market surveillance

Why Organizations Miss Emerging Product Risk: Understanding the engineering mechanisms that remain hidden long before complaint trends become visible

By Aalap Patel, MS, CQE, CSSBB

…Total Product Life Cycle Advisory Program ISO 13485:2016 ISO 14971:2019 EU MDR 2017/745 Article 83 MDCG Guidance on Post-Market Surveillance and PSUR IMDRF Post-Market Surveillance Guidance FDA Human Factors Guidance…

…Total Product Life Cycle Advisory Program ISO 13485:2016 ISO 14971:2019 EU MDR 2017/745 Article 83 MDCG Guidance on Post-Market Surveillance and PSUR IMDRF Post-Market Surveillance Guidance FDA Human Factors Guidance…

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post market surveillance

From Compliance to Clinical Action: Fixing the Broken Loop in Post-Market Surveillance

By Aalap Patel, MS, CQE, CSSBB

…FDA 21 CFR Part 820 – Quality System Regulation. Regulation (EU) 2017/745 on Medical Devices (EU MDR). ISO 14971:2019 Medical Devices — Application of Risk Management to Medical Devices. ISO…

…FDA 21 CFR Part 820 – Quality System Regulation. Regulation (EU) 2017/745 on Medical Devices (EU MDR). ISO 14971:2019 Medical Devices — Application of Risk Management to Medical Devices. ISO…

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navigating regulatory strategy

Beyond Reporting: Realizing Continuous Safety Surveillance for Medical Devices

By Jonathan Messer

…Commission: https://ec.europa.eu/tools/eudamed/#/screen/home [2] US FDA, FDA Activities Related to Essure. Bayer discontinued US sales of Essure at end of 2018 following a black box warning (2016), sales restrictions (April 2018),…

…Commission: https://ec.europa.eu/tools/eudamed/#/screen/home [2] US FDA, FDA Activities Related to Essure. Bayer discontinued US sales of Essure at end of 2018 following a black box warning (2016), sales restrictions (April 2018),…

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The 510(k) Pathway in 2026: Navigating a Shifting Regulatory and Political Landscape for Medical Devices

By Partha Anbil

…January 16). MDR Data Files. https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/mdr-data-files [7] U.S. Government Accountability Office. (2025, December 12). Medical Device Recalls: HHS and FDA Should Address Limitations in Oversight of Recall Process (GAO-26-107619). https://www.gao.gov/products/gao-26-107619…

…January 16). MDR Data Files. https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/mdr-data-files [7] U.S. Government Accountability Office. (2025, December 12). Medical Device Recalls: HHS and FDA Should Address Limitations in Oversight of Recall Process (GAO-26-107619). https://www.gao.gov/products/gao-26-107619…

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MedTech Commercialization

Decision Criteria for Technology Commercialization of Medical Devices in 2026

By Partha Anbil

…in an increasingly skeptical marketplace. Global Regulatory Harmonization Commercialization decisions can no longer be made through a purely domestic lens. The European Union’s Medical Device Regulation (MDR) continues to impose…

…in an increasingly skeptical marketplace. Global Regulatory Harmonization Commercialization decisions can no longer be made through a purely domestic lens. The European Union’s Medical Device Regulation (MDR) continues to impose…

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Regulatory

MTI Regulatory Roundup: global medical device regulatory update

By MedTech Intelligence Staff, Randy Knotts

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…

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Aligning MedTech Compliance

Navigating U.S.-EU Medical Device Regulation: Innovative Strategies for Global Compliance

By Holger Wagner

…Internal Audit Report on RA Efficiency. Link: [Not publicly available – Internal document] [3] European Commission. (2021). Regulation (EU) 2017/745 on Medical Devices. Link: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745 [4] Makary, M. A. (2023)….

…Internal Audit Report on RA Efficiency. Link: [Not publicly available – Internal document] [3] European Commission. (2021). Regulation (EU) 2017/745 on Medical Devices. Link: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745 [4] Makary, M. A. (2023)….

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Disruptive Innovation in MedTech

Disruptive Innovation in MedTech: Evolving Characteristics and Modern Realities

By Partha Anbil

…post-market data tools coexist with the end of Chevron deference, increasing the premium on robust evidence strategies and early, expert regulatory engagement for innovators and incumbents. Europe’s MDR timing relief…

…post-market data tools coexist with the end of Chevron deference, increasing the premium on robust evidence strategies and early, expert regulatory engagement for innovators and incumbents. Europe’s MDR timing relief…

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