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Expert Review of Medical Devices Volume 14, 2017 - Issue 1
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Review

Quality criteria for medical device registries: best practice approaches for improving patient safety – a systematic review of international experiences

Charlotte Susanne NiederländerInterdisciplinary Centre for Health Technology Assessment (HTA) and Public Health (IZPH), Friedrich-Alexander-University Erlangen-Nürnberg (FAU), Erlangen, GermanyCorrespondence[email protected]
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Christine KrizaInterdisciplinary Centre for Health Technology Assessment (HTA) and Public Health (IZPH), Friedrich-Alexander-University Erlangen-Nürnberg (FAU), Erlangen, GermanyView further author information
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Peter Kolominsky-RabasInterdisciplinary Centre for Health Technology Assessment (HTA) and Public Health (IZPH), Friedrich-Alexander-University Erlangen-Nürnberg (FAU), Erlangen, GermanyView further author information
Pages 49-64 | Received 14 Aug 2016, Accepted 02 Dec 2016, Published online: 28 Dec 2016

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Mutsa Gumbie, Michelle Costa, Michael Erb & Gnanadarsha Dissanayake. (2023) Innovative technologies for reverse total shoulder arthroplasty in Australia: Market access challenges and implications for patients, decision-makers, and manufacturers. Journal of Market Access & Health Policy 11:1.
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Rosanna Tarricone, Oriana Ciani, Aleksandra Torbica, Werner Brouwer, Georges Chaloutsos, Michael F Drummond, Nicolas Martelli, Ulf Persson, Reiner Leidl, Les Levin, Laura Sampietro-Colom & Rod S Taylor. (2020) Lifecycle evidence requirements for high-risk implantable medical devices: a European perspective. Expert Review of Medical Devices 17:10, pages 993-1006.
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Khic-Houy Prang, Bill Karanatsios, Ebony Verbunt, Hui-Li Wong, Justin Yeung, Margaret Kelaher & Peter Gibbs. (2022) Clinical registries data quality attributes to support registry-based randomised controlled trials: A scoping review. Contemporary Clinical Trials 119, pages 106843.
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Antonella Campanale, Marco Ventimiglia, Daniela Minella, Letizia Sampaolo, Achille Iachino & Lucia Lispi. (2022) NATIONAL BREAST IMPLANT REGISTRY IN ITALY. COMPETENT AUTHORITY PERSPECTIVE TO IMPROVE PATIENTS’ SAFETY. PLASTIC RECONSTRUCTIVE & REGENERATIVE SURGERY 1:1, pages 34-45.
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Eric Wierda, Bas de Mol, Denns van Veghel & Corrette Ploem. (2022) New European Union law on medical devices: will it truly protect patients from malfunctioning cardiac implantable electronic devices?. European Heart Journal - Quality of Care and Clinical Outcomes 8:1, pages 1-3.
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Massimo Zecchin, Marina Torre, Eugenio Carrani, Letizia Sampaolo, Enrico Ciminello, Benedetta Ortis, Renato Ricci, Alessandro Proclemer, Gianfranco Sinagra & Giuseppe Boriani. (2021) Seventeen-year trend (2001–2017) in pacemaker and implantable cardioverter-defibrillator utilization based on hospital discharge database data: An analysis by age groups. European Journal of Internal Medicine 84, pages 38-45.
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Peter L. Kolominsky-Rabas. 2021. Innovation in Clinical Trial Methodologies. Innovation in Clinical Trial Methodologies 77 84 .
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Owoicho Adogwa, Joseph Cheng & John E. O’Toole. 2019. Quality Spine Care. Quality Spine Care 75 88 .

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