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Papers matching “conformity assessment” 7

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Assessment of Clinical Information Quality in Digital Health Technologies: International eDelphi Study
2022 Journal of Medical Internet Research article Health Professions Electronic Health Records Systems Open access

Kayode Philip Fadahunsi, Petra A. Wark, Nikolaos Mastellos, Ana Luísa Neves, J. Gallagher, Azeem Majeed, +23 more

13

citations
Insights from expert panels on the EU clinical evaluation consultation procedure
2026 Expert Review of Medical Devices review Health Professions Healthcare Regulation Open access

Hilde Bastaerts, Francesca Romana Del Vecchio, Miguel Antunes, Iordanis Sidiropoulos, Cécile Henrot, Agnieszka Ciarka, +9 more

1

citations
Critical Implications of IVDR for Innovation in Diagnostics: Input From the BioMed Alliance Diagnostics Task Force
2022 HemaSphere article Health Professions Healthcare Regulation Open access

Isabel Dombrink, Bart R. Lubbers, Loredana Simulescu, Robin Doeswijk, Olga Yu. Tkachenko, Elisabeth M. C. Dequeker, +5 more

18

citations
The New EU Regulation on In Vitro Diagnostic Medical Devices: Implications and Preparatory Actions for Diagnostic Laboratories
2021 HemaSphere article Health Professions Healthcare Regulation Open access cited by 2 patents

Bart R. Lubbers, Anke Schilhabel, Christa M. Cobbaert, David González de Castro, Isabel Dombrink, Monika Brüggemann, +2 more

58

citations
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

35

citations
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 EFORT Open Reviews article Health Professions Healthcare Regulation Open access

Alan G. Fraser, Rob G. H. H. Nelissen, Per Kjærsgaard‐Andersen, Piotr Szymański, Tom Melvin, Paul Piscoi

27

citations
Linking international registries to FHIR and Phenopackets with RareLink: a scalable REDCap-based framework for rare disease data interoperability
2025 medRxiv preprint Health Professions Electronic Health Records Systems Open access

Adam S L Graefe, Filip Rehburg, Samer Alkarkoukly, Daniel Daniš, Ana Grönke, Miriam R. Hübner, +22 more

1

citations

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