Regulatory and Certification Aspects of AI-Based Medical Instruments and Devices
A special issue of Standards (ISSN 2305-6703).
Deadline for manuscript submissions: 31 May 2025 | Viewed by 163
Special Issue Editors
Interests: digital health systems, tools and devices; health services research; applied epidemiology; implementation science; health policy; science of science
Special Issues, Collections and Topics in MDPI journals
Interests: the junction between econometrics, data science, finance, health economics and computational statistics
Special Issues, Collections and Topics in MDPI journals
Interests: methods for detecting patient safety and the quality of care; variability in healthcare, equity, and conflicts of interest in health; systematic reviews and meta-analyses
Special Issues, Collections and Topics in MDPI journals
Special Issue Information
Dear Colleagues,
This Special Issue (SI) titled "Regulatory and Certification Aspects of AI-Based Medical Instruments and Devices" explores the regulatory challenges and advancements associated with digital and AI-based medical instruments and devices. The core of this SI will include original articles and studies describing regulatory pathways, certification processes, and compliance aspects of deploying AI tools, such as software-as-a-medical device (SaMD), AI-based medical devices, and decision support systems.
A focus will be on real-world evidence/experience, including studies or opinion pieces that elucidate the regulatory pathways and issues of AI applications in healthcare. These studies should discuss the practical benefits, limitations, and value of deploying AI technologies in healthcare. By publishing such experiences, this SI aims to illuminate the pathways through which AI can meet regulatory standards and be translated from bench to bedside, to improve diagnostic accuracy, treatment personalization, patient monitoring, and overall healthcare delivery.
Furthermore, this SI will accept studies and opinion papers reviewing and discussing regulatory guidelines and regulations such as the AI Act, MDR, and FDA systems.
Dr. Davide Golinelli
Dr. Andrea Bucci
Prof. Dr. Dario Tedesco
Dr. Marianna Mastroroberto
Guest Editors
Manuscript Submission Information
Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 100 words) can be sent to the Editorial Office for announcement on this website.
Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Standards is an international peer-reviewed open access quarterly journal published by MDPI.
Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 1000 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.
Keywords
- digital health
- artificial intelligence
- medical devices
- software as a medical device
- regulatory
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