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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 -
Empowering regulatory science for medical devices in Europe2026 The Lancet Regional Health - Europe article Health Professions Healthcare Regulation Open access
Alan G. Fraser, Robert A. Byrne, Elisabeth M. C. Dequeker, Per Kjærsgaard‐Andersen, Sanja Kolaček, Tom Melvin (16298975), +3 more
0citations -
Data Resource Profile: Extramural Leiden University Medical Center Academic Network (ELAN)2024 International Journal of Epidemiology article Health Professions Medical Coding and Health Information Open access
Janet M Kist, Hedwig M. M. Vos, Rimke Cathelijne Vos, Albert T.A. Mairuhu, Jeroen Nathan Struijs, Robert R. J. M. Vermeiren, +10 more
25citations -
MT3 Completeness and Concordance between Electronic Medical Records (EMR) and Submitted Insurance Claims in German Hospitals Utilizing Percutaneous Left Ventricular Assist Devices (PLVADS): Considerations for Outcomes Research
J Unterkofler, B Warich, T Brand, A Richter, Armin A. Klesius, SI Tsintzos, +1 more
0citations -
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 -
Oncologists' Communication About Uncertain Information in Second Opinion Consultations: A Focused Qualitative Analysis2021 Frontiers in Psychology article Health Professions Patient-Provider Communication in Healthcare Open access
Jamie Lee van Someren, Vicky Lehmann, Jacqueline M. Stouthard, Anne Margarethe Stiggelbout, Ellen M. A. Smets, Marij A. Hillen
7citations -
Standardized assessment of evidence supporting the adoption of mobile health solutions: A Clinical Consensus Statement of the ESC Regulatory Affairs Committee2024 European Heart Journal - Digital Health article Health Professions Mobile Health and mHealth Applications Open access
Enrico Gianluca Caiani, Hareld Kemps, Petra Hoogendoorn, Riccardo Asteggiano, Allan Böhm, Britt Borregaard, +18 more
32citations -
Characterizing and quantifying low-value diagnostic imaging internationally: a scoping review2022 BMC Medical Imaging article Health Professions Healthcare cost, quality, practices Open access cited by 1 patent
Elin Kjelle, Eivind Richter Andersen, Arne Magnus Krokeide, Lesley J. J. Soril, Leti van Bodegom‐Vos, Fiona M Clement, +1 more
100citations -
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 -
Diagnosis and treatment of neurogenic dysphagia – S1 guideline of the German Society of Neurology2021 Neurological Research and Practice article Health Professions Dysphagia Assessment and Management Open access
Rainer Dziewas, Hans–Dieter Allescher, Ilia Aroyo, Gudrun Bartolome, Ulrike Beilenhoff, Jörg Edgar Bohlender, +19 more
131citations -
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 -
Costs and Time Loss from Pre-Anesthesia Consultations for Canceled Surgeries: A Retrospective Study at Aachen University Hospital in Germany2025 Anesthesia Research article Health Professions Healthcare Operations and Scheduling Optimization Open access
Steffen B. Wiegand, Lisa Thiehoff, Patrick Winnersbach, Gereon Schälte, Anna Fischbach
1citations -
Ultrasound-guided placement of central venous catheters: A comprehensive guide for the clinician2020 Data Archiving and Networked Services (DANS) article Health Professions Central Venous Catheters and Hemodialysis
Thei Sybe Steenvoorden, Jorge López Matta, David J. van Westerloo, Pieter Roel Tuinman
2citations -
Interventions to reduce low-value imaging – a systematic review of interventions and outcomes2021 BMC Health Services Research review Health Professions Healthcare cost, quality, practices Open access
Elin Kjelle, Eivind Richter Andersen, Lesley J. J. Soril, Leti van Bodegom‐Vos, Bjørn Hofmann
92citations