Standard IEC 62304 - Medical device software - Software lifecycle processes

Cited by (245)

Items 201–245 of 245

1. A Novel University Course on Medical Devices Design and Certification at the University of Siena
   Ernesto Iadanza · 2024 · World Congress on Medical Physics and Biomedical Engineering, September 7 - 12, 2009, Munich, Germany
2. An Agile-Based Framework for Addressing Defects in Medical Device Software Development
   Misheck Nyirenda, Martin McHugh, Róisín Loughran, Fergal McCaffery · 2024 · Communications in computer and information science
3. On the Legal Aspects of Responsible AI: Adaptive Change, Human Oversight, and Societal Outcomes
   Daria Onitiu, Vahid Yazdanpanah, Adriane P. Chapman, Enrico Gerding, Stuart E. Middleton, Jennifer A. Williams · 2024 · Lecture notes of the Institute for Computer Sciences, Social Informatics and Telecommunications Engineering
4. CyMed: A Framework for Testing Connected Medical Devices
   Christopher Scherb, Adrian Hadayah, Luc Bryan Heitz, Hermann Grieder, Petra Maria Asprion · 2024 · Communications in computer and information science
5. Software in Metrology for the Digital Age: Addressing Compliance Challenges with MID, NAWID, and MDR
   Martin Koval, Jiří Tesař, Martin Staněk, Jaroslav Foltýnek · 2025 · EPJ Web of Conferences
6. A Framework for Requirements Modeling of Safety Critical Systems: A Continuous Glucose Monitoring System Case Study
   Aiman Gannous, Ramadan Abdunabi, Abdelfattah Elbarsha · 2025 · Communications in computer and information science
7. A proposed reference model for the deployment of an integrated ai system in a large oncology center under the EU AI Act and MDR. Part I: Strategic & Operational Framework
   Mateusz Dąbkowski, Dominik Wawrzuta, Ewelina Żarłok, Andrzej W. Jankowski, Lech Polkowski, Andrzej Skowron, Piotr Artiemjew · 2025 · Technical Sciences
8. 1985–1995: The Power of Computers
   Meral L. Reyhan, Salma K. Jabbour · 2025 · Springer eBooks
9. Software Tool Qualification: A Systematic Literature Review
   Giovanni Costa, Luiz Eduardo Galvão Martins · 2025 · Journal of Software Engineering Research and Development
10. AI-Enabled Predictive Maintenance of Medical Equipment for Energy and Waste Reduction
    Yuan Zhi Leong, Wai Yie Leong · 2026 · IEEE Eurasia Conference on Biomedical Engineering, Healthcare and Sustainability (ECBIOS)
11. L’intelligence artificielle : une nouvelle ère d’automatisation en laboratoire de microbiologie clinique
    Jean‐Philippe Rasigade · 2026 · Revue Francophone des Laboratoires
12. Uncertainty-Driven Risk Evaluation for Safety-Critical Software Under Conflicting Evidence Judgments: A Dual-Dimensional Evidence Fusion Approach
    Wenguang Xie, Wuhan Yang, Kenian Wang · 2026 · Symmetry
13. Proving the Path: Validating Functional‐Outcomes‐Driven Tailoring (FODT) Through Practical Applications
    Barend Botha · 2026 · Insight
14. Integrating safety and security in research: toward a unified framework for Latin American institutions
    Luiz Eduardo Galvão Martins, Silvina E. Fioressi, Daniel E. Bacelo · 2026 · Science and Public Policy
15. Patient-tailored brachytherapy applicator development in compliance with the EU medical device regulation
    Robin Straathof, Sharline M. van Vliet‐Pérez, Linda S. G. L. Wauben, Ben J.M. Heijmen, Henrike G. Westerveld, Jenny Dankelman, Remi A. Nout, Inger‐Karine K. Kolkman‐Deurloo, Nick J. van de Berg · 2026 · Physica Medica
16. Digital therapeutics in cancer management and the emerging role of digital phenotyping
    Bicong Cong, Bingru Xu, Xuchen Chen, Yangming Ou, Xiang Li, Kevin Liu, Shaohan Zhang, Chunyu Fu, Junxiang Fan, Zelei Liu et al. · 2026 · Displays
17. Introduction
    Ajit Pandey, Pramod Gupta, Naresh Kumar Sehgal · 2026 · Springer eBooks
18. A comparative analysis of deep learning models for disease classification in multi-organ histopathological images
    Jong‐ryul Choi, Sungjun Jang, Sung Suk Oh, Ji Yun Lee, Kyujung Kim, Taegeun Oh · 2026 · Scientific Reports
19. Safety and Reliability Evaluation of Medical Chatbots Powered by Large Language Models
    Elvira Nurfadhilah, Lyla Ruslana Aini, Agung Santosa, Mohammad Teduh Uliniansyah, Gunarso Gunarso, Prabu Kresna Putra, Siska Pebiana, Radhiyatul Fajri, Nuraisa Novia Hidayati, Rahardito Dio Prastowo et al. · 2026 · Advances in computational intelligence and robotics book series
20. Structuring trust: a quantitative and traceable framework for hardware security assurance
    Shao-Fang Wen, Arvind Sharma · 2026 · International Journal of Information Security
21. AI-Based Medical Devices: Example of Conformity Assessment
    Thomas Schmid, Wolfgang Hildesheim, Taras Holoyad · 2026 · Springer eBooks
22. Embedding Formal Worst-Case Latency Proofs and Memory-Safety Certificates into the snn-mlir MLIR Lowering Pipeline for IEC 62304-Compliant Edge Deployment of Spiking Neural Networks
    Hassan Farooq · 2026 · Research Square
23. Simulation as a Medical Device
    Sven Herrmann, Alexander Pugachev, Windi Hary, Jan Hertwig · 2026 · Springer eBooks
24. A Safety-First Approach to Health AI
    Nicoleta Economou-Zavlanos, Elisabeth R. Garwood, Suchi Saria, David Westfall Bates, An-Kwok Ian Wong, Matthew Elmore, Rachael Weir, Tom Ford, Kevin Gormley, Chris Jackson et al. · 2026 · The American Journal of Bioethics
25. Beyond Detection Limits: Integrated Biosensors for Molecular Diagnostics, Longitudinal Monitoring, and Clinical Translation
    Nilanjan Roy, Michael Powers, Minelly Gonzalez, Luca Cucullo · 2026 · Biosensors
26. The Decision Twin: Metaverse Patient Digital Twins as Executable Clinical Reality
    Filippo Cenacchi, Longbing Cao, Deborah Richards · 2026 · ACM SIGKDD Conference on Knowledge Discovery and Data Mining (KDD)
27. Beyond the Device: A Digital Infrastructure Framework for Sustainable Point-of-Care Diagnostic Services in Low-Resource and Infrastructure-Constrained Settings
    Ingeborg M. Rocker, Kabir S. Patel · 2026 · Diagnostics
28. Advances in Pneumatic Upper-Limb Rehabilitation Robots: A Critical Review of Structural Design, Human–Robot Interaction, and Clinical Translation
    Yonggen Zhao, Yeming Zhang, Maolin Cai, Feng Wei · 2026 · Robotics
29. Translating smart biosensors for metabolic health: Regulatory pathways, ethical governance and commercialization strategy
    Kanwal Rehman, Muhammad Sajid Hamid Akash · 2026 · Elsevier eBooks
30. Crossing Industry Boundaries: A Case Study on Enhancing Medical Devices Software Development Using Automotive SPICE® Practices
    Noha Moselhy, Dina Elhakim, Yosry Mohsen · 2026 · Communications in computer and information science
31. Design of a Wireless-Controlled Powered Transport Chair with Transfer-Assist Functions and Integrated Seated Weight Measurement
    Charin Intarapanich, Sittinun Tawkaew, Teerapath Limboonruang, Nittalin Phunapai · 2026 · Inventions
32. Evaluation of a Fuzzy-Supervised PID Controller for a Parallel Rehabilitation Mechanism
    Adriana Daniela Banyai, Daniel Banyai, Cornel Brișan · 2026 · Bioengineering
33. Challenges and Recommendations in Regulating AI Medical Devices in the European Union: A Scoping Review
    Guilherme Semedo, Emanuel Valpaços, Liliana Maria Rodrigues Teles, Bruno Gago, Nelson Pacheco Rocha · 2026 · Healthcare
34. A Multimodal Therapist-Supervised Robotic Gait-Training Platform with Phase-Synchronized Infrared Thermal Biofeedback: A Concept-Level Technical and Translational Healthcare Framework
    Rocco Salvatore Calabrò, Aurelio Crespantini, Andrea Calderone, Stefano Troncone · 2026 · Healthcare
35. A Review of CMOS-Compatible Flexible Biosensors Based on Polymer Electronics for Wearable Healthcare
    Ava Hedayatipour, Sara Moghtadernejad · 2026 · Chips
36. Improving Verification & Validation in the Medical Device Domain
    M. S. Sivakumar, Valentine Casey, Fergal McCaffery, Gerry Coleman · 2011 · Communications in computer and information science
37. Verification & Validation in Medi SPICE
    M. S. Sivakumar, Valentine Casey, Fergal McCaffery, Gerry Coleman · 2011 · Communications in computer and information science
38. Towards Agentic Refactoring for Autonomous Maintenance in Smart Infusion Pumps*
    Leya El Halabi, Ali Hamza Salman, Ernesto Iadanza · 2026 · World Congress on Medical Physics and Biomedical Engineering, September 7 - 12, 2009, Munich, Germany
39. Toward Metrology-Grade Multimodal AI in Medical Imaging: A Conceptual Framework for Uncertainty-Aware and Traceable Measurement Pipelines
    Éxaucé Maruba Kambale, Christian Kutabuna Kubakisa, Witesyavwirwa Vianney Kambale, Jean-Pierre Mugisha Muhire, Gédéon Nkishi Djenga, Roméo Miantezolo, David Bumande Samasanda, Josué Lungi Selemani, Samuel Matia Kangoni, Simon Ntumba Badibanga et al. · 2026 · Procedia Computer Science
40. Design and Construction of a Hand Rehabilitation Prototype and Development of Web and Mobile Interface Proposals for Rheumatoid Arthritis
    Oscar Gabriel Vizcaíno Monroy, Pablo Velarde-Alvarado, Perla Aguilar Navarrete, Luis Aníbal López Arciniega · 2026 · International Multidisciplinary Journal of Emerging Technologies and Applications
41. Engineering magnetic soft materials for biomedical applications
    Xurui Liu, Neng Xia, Kai Fung Chan, Joseph J.�Y. Sung, Philip Wai Yan Chiu, Liu Wang, Li Zhang · 2026 · Nature Reviews Materials
42. Validation and optimisation of wearable accelerometer data pre-processing for digital measure implementation and development
    Joss Langford, Jia Ying Chua, Ian Long, Alan C. Williams, Melvyn M. Hillsdon · 2026 · PLoS ONE
43. Research and Development Process, Regulatory Requirements and Clinical Trial of Medical Devices: A Review within the Framework of the Turkish Medicines and Medical Devices Agency (TITCK) and the European Union (Regulation 2017/745)
    Umut Doğu Seçkin, Aylin Buhur, Yiğit Uyanıkgil · 2026 · Uludağ Üniversitesi Tıp Fakültesi Dergisi
44. Using digital twins as a shared information model for secure software lifecycle management in IoT
    Rustem Dautov, Hui Song, Arda Göknil, Adela Nedisan Videsjorden · 2026 · Discover Computing
45. Software for Medical Systems
    Jeff Geisler · 2009 · Elsevier eBooks