Original Research
Accepted on 28 Sep 2026
A PBMC-based proof-of-principle framework for fit-for-purpose validation of flow cytometry assays in cell therapy development
in Regulatory Affairs
Frontiers in Medical Technology
- 196 views
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80 articles
articles
Original Research
Published on 18 Sep 2026
Approval lag and loss for biologic-device combination products in Japan and the United States
in Regulatory Affairs
Frontiers in Medical Technology
doi 10.3389/fmedt.2026.1924169
- 830 views
Review
Published on 02 Sep 2026
Systematic review of 3D-printed surgical devices for austere environments: an evaluation guideline
in Regulatory Affairs
Frontiers in Medical Technology
doi 10.3389/fmedt.2026.1908227
- 1,351 views
Original Research
Published on 02 Jul 2026
Member selection in traditional Chinese medicine innovation consortia: an evolutionary game theory approach
in Regulatory Affairs
Frontiers in Medical Technology
doi 10.3389/fmedt.2026.1786671
- 3,548 views
Systematic Review
Published on 24 Jun 2026
Reported best practices for effective risk management of medical devices: a scoping review
in Regulatory Affairs
Frontiers in Medical Technology
doi 10.3389/fmedt.2026.1863808
- 4,989 views
Systematic Review
Published on 24 Jun 2026
Methodologies for generating and evaluating clinical and performance evidence for high-risk and innovative medical devices and in vitro diagnostics: a scoping review
in Regulatory Affairs
Frontiers in Medical Technology
doi 10.3389/fmedt.2026.1857401
- 8,584 views
- 1 citation
Original Research
Published on 19 Jun 2026
Efficacy assessment in trials of complex and rare diseases: a comparison between the meta-analytic global statistical test and co-primary analysis
in Regulatory Affairs
Frontiers in Medical Technology
doi 10.3389/fmedt.2026.1819463
- 5,814 views
- 1 citation
Policy and Practice Reviews
Published on 09 Jun 2026
China's regulatory regime for medical biotechnology: evolution, challenges, and future perspectives
in Regulatory Affairs
Frontiers in Medical Technology
doi 10.3389/fmedt.2026.1805452
- 7,320 views
Original Research
Published on 28 May 2026
Effectiveness of electropolishing step on elimination of upstream manufacturing material residues on metallic orthopaedic medical device
in Regulatory Affairs
Frontiers in Medical Technology
doi 10.3389/fmedt.2026.1803156
- 4,619 views
Review
Published on 20 Mar 2026
Dental devices and antimicrobial resistance: challenges, innovations, and regulatory compliances
in Regulatory Affairs
Frontiers in Medical Technology
doi 10.3389/fmedt.2026.1750006
- 10,329 views
- 3 citations
Original Research
Published on 11 Mar 2026
Structure and legibility of informed consent for clinical practice in Ecuador
in Regulatory Affairs
Frontiers in Medical Technology
doi 10.3389/fmedt.2026.1774341
- 1,640 views
Policy and Practice Reviews
Published on 13 Feb 2026
Early and accelerated access programs for medical devices in the European Union: mapping regulatory derogations and national schemes
in Regulatory Affairs
Frontiers in Medical Technology
doi 10.3389/fmedt.2026.1729631
- 3,920 views
- 2 citations
Review
Published on 03 Feb 2026
Enhancing the digital adoption in healthcare built environments: a framework for a therapeutic user-based wayfinding system
in Regulatory Affairs
Frontiers in Medical Technology
doi 10.3389/fmedt.2025.1323446
- 3,443 views
Correction
Published on 16 Jan 2026
Correction: A hybrid, iterative approach, to support the development of fit-for-purpose sensor-derived measures
in Regulatory Affairs
Frontiers in Medical Technology
doi 10.3389/fmedt.2025.1756558
- 1,532 views
Editorial
Published on 19 Nov 2025
Editorial: Healthcare technologies and space: therapeutic built environment as a health technology and technologies for improved healthcare settings
in Regulatory Affairs
Frontiers in Medical Technology
doi 10.3389/fmedt.2025.1726059
- 2,750 views
- 1 citation
Perspective
Published on 30 Oct 2025
A hybrid, iterative approach, to support the development of fit-for-purpose sensor-derived measures
in Regulatory Affairs
Frontiers in Medical Technology
doi 10.3389/fmedt.2025.1567537
- 2,616 views
- 1 citation
Review
Published on 15 May 2025
Regulatory landscape of accelerated approval pathways for medical devices in the United States and the European Union
in Regulatory Affairs
Frontiers in Medical Technology
doi 10.3389/fmedt.2025.1586070
- 20,761 views
- 37 citations
Mini Review
Published on 09 May 2025
Regulatory aspects of optogenetic research and therapy for retinitis pigmentosa under EU law
in Regulatory Affairs
Frontiers in Medical Technology
doi 10.3389/fmedt.2025.1548927
- 6,845 views
- 3 citations
Policy Brief
Published on 03 Feb 2025
Survey of Notified Bodies reveals very limited use of conditional certification for high-risk medical devices
in Regulatory Affairs
Frontiers in Medical Technology
doi 10.3389/fmedt.2025.1504294
- 5,804 views
- 5 citations
Review
Published on 16 Dec 2024
US regulatory compliance for medical combination products: an overview
in Regulatory Affairs
Frontiers in Medical Technology
doi 10.3389/fmedt.2024.1486318
- 12,127 views
- 30 citations
Mini Review
Published on 28 Nov 2024
Navigating regulatory and policy challenges for AI enabled combination devices
in Regulatory Affairs
Frontiers in Medical Technology
doi 10.3389/fmedt.2024.1473350
- 14,558 views
- 60 citations
Perspective
Published on 12 Nov 2024
An approach to reduce inhaler errors using Donabedian's triad
in Regulatory Affairs
Frontiers in Medical Technology
doi 10.3389/fmedt.2024.1494089
- 7,215 views
- 4 citations
Original Research
Published on 06 Aug 2024
Trends in the market for drug delivery devices categorized as combination drugs and medical devices and regulatory challenges for autoinjectors in Japan
in Regulatory Affairs
Frontiers in Medical Technology
doi 10.3389/fmedt.2024.1461460
- 6,410 views
- 7 citations
Review
Published on 10 Jul 2024
Ensuring safety and efficacy in combination products: regulatory challenges and best practices
in Regulatory Affairs
Frontiers in Medical Technology
doi 10.3389/fmedt.2024.1377443
- 13,485 views
- 68 citations