scholarly journals PRM144 Cardiologists' Knowledge and Awareness of Guidelines for Medical Device Safety and Product Risk Management

2012 ◽  
Vol 15 (7) ◽  
pp. A486-A487
Author(s):  
R. Bozkurt ◽  
J. Yildirim
Keyword(s):  
Risk Management ◽  
Medical Device ◽  
Medical Device Safety ◽  
Product Risk

Recent Updates on Medical Device Safety and Risk Management

2020 ◽  
pp. 901-919
Author(s):  
Sheersha Pramanik ◽  
Namdev More ◽  
Govinda Kapusetti ◽  
Rakesh K. Tekade
Keyword(s):  
Risk Management ◽  
Medical Device ◽  
Medical Device Safety

Out-of-the-Box Medical Device Safety

2016 ◽  
Vol 5 (1) ◽  
pp. 84-85
Author(s):  
Shannon Clark ◽  
Divya Natesan ◽  
Morgan Walker ◽  
Denise Forkey
Keyword(s):  
Risk Analysis ◽  
Medical Device ◽  
Usability Study ◽  
Device Design ◽  
Medical Device Design ◽  
Safety Risks ◽  
Related Risk ◽  
Medical Device Safety

Out-of-the-box experience is an important consideration in medical device design that not only impacts the user’s impression of the product, but can also have critical safety implications. This article discusses the basic safety questions to contemplate in a use-related risk analysis pertaining to the out-of-the-box experience, and focuses on how the most critical safety risks can be reduced or eliminated by conducting a usability study related to the out-of-the-box experience.

Embracing Cybersecurity Risk Management in the Industry of Medical Devices

2018 ◽  
pp. 177-197 ◽  
Author(s):  
Maria Lai-Ling Lam ◽  
Kei Wing Wong
Keyword(s):  
Risk Management ◽  
Local Government ◽  
Medical Device ◽  
Medical Devices ◽  
Industry 4.0 ◽  
Life Cycles ◽  
Shared Responsibility ◽  
Operating Environments ◽  
Set Up ◽  
Industry Needs

The promises of Industry 4.0 in the medical device industry needs to be built on sound cybersecurity infrastructures, polices, and practices. During 2011-2017, the authors interviewed many manufacturers of medical devices in China, Germany, Israel, Japan, Taiwan, and U.S. about their attitude towards cybersecurity. Many manufacturers are not committed to cybersecurity risk management because they pursue lower cost and shorter product life cycles; do not have sufficient knowledge of operating environments of hospitals; have defensive attitude toward vulnerability disclosure; and reap quick benefits from the low-trust level among stakeholders and unequal power between manufacturers and distributors. Only a few large U.S. manufacturers of medical devices have set up robust secure platforms and interoperable optimal standards which benefit the users. As cybersecurity is a shared responsibility, many small and medium-sized enterprises need to be empowered through the support of international organizations and local government policies.

Security and Privacy Concerns of Virtual Worlds

2011 ◽  
pp. 244-256
Author(s):  
Greg Gogolin
Keyword(s):  
Risk Management ◽  
Resource Management ◽  
Virtual Worlds ◽  
Security And Privacy ◽  
Access Management ◽  
Security Risks ◽  
Privacy Concerns ◽  
The Core ◽  
Product Risk ◽  
Virtual Meetings

This chapter looks at security and privacy concerns of virtual worlds by investigating the use and capabilities of current and emerging technologies such as gaming, blogging, podcasting, virtual meetings, and virtual worlds. Security and privacy concerns will be investigated in the context of exploits and IT-related security risks, access management and confidentiality, reputation and product risk management, resource management, financial considerations and accountability, and safety. Several technologies and personal practices are reviewed, as well as ways to mitigate or eliminate their associated risks. The core principles of information security -confidentiality, integrity, and availability - provide an overall framework for the chapter.

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