This paper is in the following e-collection/theme issue:

New Technologies (96) Viewpoints on and Experiences with Digital Technologies in Health (89) E-Health Policy and Health Systems Innovation (296) Policy and Policy Proposals (139) Regulatory Issues and Medical Device Certification (5) Design and Usability of Clinical Software and EHRs (308)

Published on in Vol 12 (2024)

Preprints (earlier versions) of this paper are available at https://preprints.jmir.org/preprint/58080, first published .
Exploring Impediments Imposed by the Medical Device Regulation EU 2017/745 on Software as a Medical Device

Exploring Impediments Imposed by the Medical Device Regulation EU 2017/745 on Software as a Medical Device

Exploring Impediments Imposed by the Medical Device Regulation EU 2017/745 on Software as a Medical Device

Authors of this article:

Liga Svempe1 Author Orcid Image
Article Authors Cited by (5) Tweetations Metrics

Journals

  1. Rimpi , Verma S, Pinky , Baldi A. Evidence-based recommendations for comprehensive regulatory guidelines in medical devices: the imperative for global harmonization. Naunyn-Schmiedeberg's Archives of Pharmacology 2025 View
  2. Ujjwal R, Slaughter G. Advances in Bacterial Cellulose‐Based Scaffolds for Tissue Engineering: Review. Journal of Biomedical Materials Research Part A 2025;113(4) View
  3. Rao K, Fernandez-Alvarez V, Guntinas-Lichius O, Sreeram M, de Bree R, Kowalski L, Forastiere A, Pace-Asciak P, Rodrigo J, Saba N, Ronen O, Florek E, Randolph G, Sanabria A, Vermorken J, Hanna E, Ferlito A. The Limitations of Artificial Intelligence in Head and Neck Oncology. Advances in Therapy 2025;42(6):2559 View
  4. Martjan R, Weimar S, Terzidis O. A Business Model Framework for Software as a Medical Device Startups in the European Union: Mixed Methods Study. Journal of Medical Internet Research 2025;27:e67328 View

Books/Policy Documents

  1. Jacob J, Unnimaya M, Ramlath B, Varghese T. Innovations and Applications of Advanced Biomaterials in Healthcare and Engineering. View