Methodologies for generating and evaluating clinical and performance evidence for high-risk and innovative medical devices and in vitro diagnostics: a scoping review
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Author(s):
Nensi Bralić, Ružica Bandić, Miro Vuković, Danira Matijaca, Renata Valsami, Panagiotis Zoumpoulakis, Kalle Schnitzer, Mari Levula, Risto Roine, Antti Viitala, Antti Pihlava, Olivia McDermott, Ana Marušić
Published in:
Frontiers in Medical Technology, Issue 8, 2026, ISSN 2673-3129
Publisher:
Frontiers Media SA
DOI:
10.3389/FMEDT.2026.1857401
Methodologies for mapping existent common specification, standards, and overlapping regulation for medical devices: a scoping review
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Author(s):
Francisco Teixeira, Carolina Travassos, Inês Urbano, Ioanna Kostopoulou, João Quintas, Kshitij Sharma, Maria Karela, Mariana Cláudio, Panagiotis Zoumpoulakis, Sílvia Antunes, Ana Brito
Published in:
Expert Review of Medical Devices, Issue 23, 2026, ISSN 1743-4440
Publisher:
Informa UK Limited
DOI:
10.1080/17434440.2026.2669666