Regulatory Issues Encountered in the Process of Medical Device Project Management

DOI: https://doi.org/10.62517/jbm.202409303

Author(s)

Wang Haotian1, Fang Xiaoyu1, Zhang Jie2, Jiang Zhenyu1, Dai Xiaoyu1, Gu Yinglei1, Sun Chuanheng1, Peng Chenghua3, Bu Qingfeng1,4,*

Affiliation(s)

1School of Medical Instruments, Shanghai University of Medicine and Health Sciences, Shanghai, China 2ShangHai ZhouPu Hospital Affiliated to SUMHS, Shanghai, China 3Jining Technical College,Jining,China 4School of Economics, Shandong University, Jinan, China *Corresponding Author

Abstract

The medical device industry is subject to rigorous regulatory frameworks aimed at ensuring the safety, efficacy, and quality of medical devices. This paper explores the regulatory challenges encountered during the project management of medical device development and commercialization. These challenges include navigating complex and frequently changing regulatory standards, managing lengthy and intricate approval processes, and ensuring compliance with quality and safety requirements across different jurisdictions. The study also highlights the difficulties associated with intellectual property protection, ethical review processes for clinical trials, and the growing demands for environmental sustainability in device manufacturing and disposal. Through a comprehensive review of literature and analysis of case studies, this research identifies key obstacles in regulatory compliance and offers insights into strategies for effective project management in the medical device sector. The findings suggest that successful navigation of regulatory challenges requires a multifaceted approach, including the adoption of advanced management software, continuous professional development, and proactive engagement with regulatory bodies. The paper concludes with recommendations for medical device firms to enhance their project management practices, thereby facilitating smoother regulatory compliance and faster market access for innovative medical technologies.

Keywords

Medical Devices; Enterprise Project Management; Regulatory Issues

References

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