Construction Practice of Medical Device Product Life Cycle Management Platform
Journal: Journal of Clinical Medicine Research DOI: 10.32629/jcmr.v5i1.1776
Abstract
Medical device product life cycle management is one of the core contents of medical device quality management system construction, spanning the entire process of enterprise core business activities including market, research and development, procurement, production, and services. Building a comprehensive and efficient life cycle management system facilitates the implementation of quality management systems. Taking the example of the construction of a unified product life cycle management platform for medical device hardware and software that has been launched and operated, this article describes the general principles and practical experience of constructing a medical device life cycle management platform, including requirements collection, system design, product selection, customization development and confirmation, as well as platform trial, acceptance commissioning, and operation and maintenance management.
Keywords
life cycle management, quality management, maturity
Funding
The Development Special Project of Ping Shan District Innovation Platform Construction Project (Contract No.: 29853M-KCJ-2023-002-24) in 2022
Full Text
PDF - Viewed/Downloaded: 1 TimesIndexation
Download Index RecordReferences
[1] Yang Xueying. Research on the Full Life Cycle Management of Class III Medical Device R&D Projects. Qingdao University of Science and Technology, 2017.
[2] Dong Hua, Jiang Zhenzhen, Yang Xueying. Research on the Full Life Cycle Management of Class III Medical Device R&D Projects. Project Management Technology, 2017, 15(6): 48-52.
[3] Jiang Lei, Tan Xiaojun. Research on the Full Life Cycle Management of Class III Medical Device R&D Projects. Product Reliability Report, 2023(07): 39-40.
[4] Ye Senyan. Research on the Full Life Cycle Management of Medical Device R&D Projects. China Equipment Engineering, 2021(16): 32-33.
[5] State Administration for Market Regulation, National Standardization Administration Committee. GBT 42061-2022 Requirements for Quality Management Systems for Medical Devices Used in Regulations, Beijing, 2022.
[6] National Medical Products Administration. YY/T 0664-2020 Medical Device Software Software Lifecycle Processes, Beijing, 2020.
[7] State Administration for Market Regulation, National Standardization Administration Committee. GBZ 42217-2022 Confirmation of Software for Medical Device Quality System Software, Beijing, 2022.
[8] National Medical Products Administration. Announcement of CFDA on the Issuance of the Production Quality Management Regulations for Medical Devices, 2014.
[9] National Medical Products Administration. Medical Device Production Quality Management Specification Appendix Independent Software, Beijing, 2019.
[10] National Medical Products Administration, Guidelines for the Inspection of Medical Device Registration Quality Management Systems, Beijing, 2022.
[11] Hisayoshi Masahiko, PLM Lifecycle Management [M], Dongfang Publishing House, 2017.
[2] Dong Hua, Jiang Zhenzhen, Yang Xueying. Research on the Full Life Cycle Management of Class III Medical Device R&D Projects. Project Management Technology, 2017, 15(6): 48-52.
[3] Jiang Lei, Tan Xiaojun. Research on the Full Life Cycle Management of Class III Medical Device R&D Projects. Product Reliability Report, 2023(07): 39-40.
[4] Ye Senyan. Research on the Full Life Cycle Management of Medical Device R&D Projects. China Equipment Engineering, 2021(16): 32-33.
[5] State Administration for Market Regulation, National Standardization Administration Committee. GBT 42061-2022 Requirements for Quality Management Systems for Medical Devices Used in Regulations, Beijing, 2022.
[6] National Medical Products Administration. YY/T 0664-2020 Medical Device Software Software Lifecycle Processes, Beijing, 2020.
[7] State Administration for Market Regulation, National Standardization Administration Committee. GBZ 42217-2022 Confirmation of Software for Medical Device Quality System Software, Beijing, 2022.
[8] National Medical Products Administration. Announcement of CFDA on the Issuance of the Production Quality Management Regulations for Medical Devices, 2014.
[9] National Medical Products Administration. Medical Device Production Quality Management Specification Appendix Independent Software, Beijing, 2019.
[10] National Medical Products Administration, Guidelines for the Inspection of Medical Device Registration Quality Management Systems, Beijing, 2022.
[11] Hisayoshi Masahiko, PLM Lifecycle Management [M], Dongfang Publishing House, 2017.
Copyright © 2024 Yueming Yang, Li Zhao, Weigang Zhu, Jicheng Quan, Yang Tang, Shengle Geng, Ming Zhong, Huiliang Wang
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License