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Papers per year
Papers 31
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The end of the laboratory developed test as we know it? Recommendations from a national multidisciplinary taskforce of laboratory specialists on the interpretation of the IVDR and its complications2020 Clinical Chemistry and Laboratory Medicine (CCLM) article Health Professions Healthcare Regulation Open access
Paul C. D. Bank, Leo H.J. Jacobs, Sjoerd A.A. van den Berg, Hanneke W. M. van Deutekom, Dörte Hamann, Richard Molenkamp, +6 more
48citations -
ISO 15189 is a sufficient instrument to guarantee high-quality manufacture of laboratory developed tests for in-house-use conform requirements of the European In-Vitro-Diagnostics Regulation2023 Clinical Chemistry and Laboratory Medicine (CCLM) article Health Professions Healthcare Regulation Open access
Florent J.L.A. Vanstapel, Matthias Orth, Thomas Streichert, Ettore Capoluongo, Wytze P. Oosterhuis, Hikmet Can Çubukçu, +10 more
46citations -
Improved clinical investigation and evaluation of high-risk medical devices: the rationale and objectives of CORE-MD (Coordinating Research and Evidence for Medical Devices)2021 European Heart Journal - Quality of Care and Clinical Outcomes article Health Professions Healthcare Regulation Open access
Alan G. Fraser, Rob G. H. H. Nelissen, Per Kjærsgaard‐Andersen, Piotr Szymański, Tom Melvin, Paul Piscoi, +80 more
35citations -
Navigating Medical Device Certification: A Qualitative Exploration of Barriers and Enablers Amongst Innovators, Notified Bodies and Other Stakeholders2022 Therapeutic Innovation & Regulatory Science article Health Professions Healthcare Regulation Open access
Rebecca Baines, Petra Hoogendoorn, Sebastian Stevens, Arunangsu Chatterjee, Liz Ashall-Payne, Tim Andrews, +1 more
31citations -
Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review2023 International Journal of Health Policy and Management review Health Professions Healthcare Regulation Open access
Lotje Anna Hoogervorst, Timon H. Geurkink, Anne Lübbeke, Sergio Buccheri, Jan W. Schoones, Marina Torre, +10 more
30citations -
Implementation of the new EU IVD regulation – urgent initiatives are needed to avert impending crisis2021 Clinical Chemistry and Laboratory Medicine (CCLM) article Health Professions Healthcare Regulation Open access
Christa M. Cobbaert, Ettore Capoluongo, Florent J.L.A. Vanstapel, Patrick M. Bossuyt, Harjit Pal Bhattoa, Peter H. Nissen, +6 more
26citations -
Urgent call to the European Commission to simplify and contextualize IVDR Article 5.5 for tailored and precision diagnostics2025 Clinical Chemistry and Laboratory Medicine (CCLM) article Health Professions Healthcare Regulation Open access
Christa M. Cobbaert, Christoph Buchta, Thomas Streichert, Florent J.L.A. Vanstapel, François Mullier, Lucas Biaggini, +5 more
12citations -
Recommended methodologies for clinical investigations of high-risk medical devices—Conclusions from the European Union CORE–MD Project2025 The Lancet Regional Health - Europe article Health Professions Healthcare Regulation Open access
Alan G. Fraser, Sergio Buccheri, Robert A. Byrne, Per Kjærsgaard‐Andersen, Stefan Karl James, Peter Jüni, +87 more
12citations -
Question‐based development of high‐risk medical devices: A proposal for a structured design and review process2023 British Journal of Clinical Pharmacology article Health Professions Healthcare Regulation Open access
Nicholas A. White, Timo J. C. Oude Vrielink, Koen E.A. van der Bogt, Adam F. Cohen, Joris I. Rotmans, Tim Horeman
7citations -
Reference, calibration and referral laboratories – a look at current European provisions and beyond2024 Clinical Chemistry and Laboratory Medicine (CCLM) article Health Professions Healthcare Regulation Open access
Christoph Buchta, Bernhard Benka, Vincent Delatour, Ingrid Faé, Andrea Griesmacher, Karina Hellbert, +9 more
7citations -
Impact of Medical Device Regulation on use of ultrasound‐based prediction models in clinical practice2024 Ultrasound in Obstetrics and Gynecology article Health Professions Healthcare Regulation Open access
Agnieszka Kotlarz, Wouter Froyman, Lil Valentin, Antonia Carla Testa, Ben Van Calster, Tom Bourne, +1 more
4citations -
Development of a minimum checklist to assess the quality of evidence produced using registry data for the evaluation of medical device safety and performance2025 BMJ Surgery Interventions & Health Technologies article Health Professions Healthcare Regulation Open access
Lotje Anna Hoogervorst, Rob G. H. H. Nelissen, Tom Melvin, Paul Piscoi, Chris Wilkinson, Anne Lübbeke, +11 more
3citations -
INSAFEDARE Project: Innovative Applications of Assessment and Assurance of Data and Synthetic Data for Regulatory Decision Support2024 Studies in health technology and informatics book-chapter Health Professions Healthcare Regulation Open access
Parisis Gallos, Nicholas Matragkas, Saif ul Islam, Gregory Epiphaniou, Stuart Harrison, M. Haas, +18 more
2citations
Most active Aachen authors
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Christa M. Cobbaert 8,703 citations overall9 papers
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Rob G. H. H. Nelissen 22,443 citations overall8 papers
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Lotje Anna Hoogervorst 213 citations overall5 papers
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Jacques J. M. van Dongen 55,067 citations overall3 papers
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Perla J. Marang‐van de Mheen 5,914 citations overall3 papers
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Joris I. Rotmans 26,291 citations overall2 papers
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Adam F. Cohen 11,184 citations overall2 papers
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Jan W. Schoones 8,289 citations overall2 papers
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Timon H. Geurkink 89 citations overall2 papers
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Ewout Willem Steyerberg 172,939 citations overall1 paper
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Ben Van Calster 42,192 citations overall1 paper
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Yvonne G. Weber 14,228 citations overall1 paper
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Jesse Joachim Swen 13,791 citations overall1 paper
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Claudia A. L. Ruivenkamp 10,749 citations overall1 paper
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Piet H. van der Graaf 6,134 citations overall1 paper