scholarly journals A Modular Endoscopy Simulation Apparatus (MESA) for Robotic Medical Device Sensing and Control Validation

2018 ◽  
Vol 3 (4) ◽  
pp. 4054-4061 ◽  
Author(s):  
Gregory A. Formosa ◽  
Joseph Micah Prendergast ◽  
Jinghui Peng ◽  
Donald Kirkpatrick ◽  
Mark E. Rentschler
Keyword(s):  
Medical Device ◽  
Endoscopy Simulation ◽  
And Control

scholarly journals Key points of technical review for the registration of SARS-CoV-2 nucleic acid tests in China

Bioanalysis ◽  
2021 ◽  
Author(s):  
Hongran Li ◽  
Tong Jiao ◽  
Peirong Wang ◽  
Juanjuan An ◽  
Gang Deng ◽  
...  
Keyword(s):  
Nucleic Acid ◽  
Medical Device ◽  
Product Safety ◽  
Technical Review ◽  
Key Points ◽  
Safety Effectiveness ◽  
Unified Command ◽  
And Control ◽  
Nucleic Acid Tests

In response to the outbreak of COVID-19, in accordance with the principles of ‘unified command, early involvement, prompt review and scientific approval’ as well as the requirements of ensuring product safety, effectiveness and controllable quality, the Center for Medical Device Evaluation (CMDE) has issued Key Points of Technical Review for the Registration of SARS-CoV-2 Nucleic Acid Tests ( Key Points) to provide the requirements of tests. Because of the sustainability of the pandemic, more efforts and attempts are needed for SARS-CoV-2 detection and control. This article interprets the Key Points issued by the CMDE and provides certain refinements to wider audiences.

Medical Device Design and Control in the Hospital

2004 ◽  
pp. 346-349 ◽  
Author(s):  
Joel R. Canlas ◽  
Jay W. Hall ◽  
Pam Shuck-Holmes
Keyword(s):  
Medical Device ◽  
Device Design ◽  
Medical Device Design ◽  
And Control

scholarly journals eHealth Spare Parts as a Service: Modular eHealth Solutions and Medical Device Reform

2017 ◽  
Vol 24 (4) ◽  
pp. 463-486
Author(s):  
Nadezhda Purtova
Keyword(s):  
Medical Device ◽  
Spare Parts ◽  
Legal Compliance ◽  
Platform As A Service ◽  
Medical Apps ◽  
Performance Requirements ◽  
And Performance ◽  
And Control ◽  
Mhealth Apps

Abstract eHealth Platform as a Service (‘PaaS’) is an innovative way to build mHealth apps out of cloud-based generic components. Having examined the current and future regimes of safety and performance, this article concludes that the ‘selling features’ of the PaaS (outsourced creation and maintenance of cloud-based parts for easy mHealth-building) undermine legal compliance, and the reform will not change this significantly. Although no safety and performance requirements apply yet to consumer eHealth, the medical apps are regulated. Their manufacturers must ensure the final apps are safe, while not being in control of the parts composing the apps. Generic components not meant for a specific medical device and their providers are not subject to safety and performance requirements. Market will likely push PaaS providers to offer mHealth manufacturers tools to ensure and control safety and performance when medical apps are concerned. I foresee no such incentives for consumer mHealth.

Standardization and Control of Biomedical Devices

1987 ◽  
Vol 110 ◽  
Author(s):  
D. Gregory Singleton
Keyword(s):  
Medical Device ◽  
Drug Administration ◽  
Regulatory Authority ◽  
Food And Drug Administration ◽  
Biomedical Devices ◽  
Huge Number ◽  
Medical Specialties ◽  
Hazard Potential ◽  
And Control ◽  
Existing Data

The passage of the Medical Device Amendements to the Food Drug and Cosmetic Act on May 28, 1976 placed a huge number of products under the regulatory authority of the Food and Drug Administration (FDA). This increased responsibility took many forms related to device evaluation which will be discussed in this paper. In order to institute control of all devices it was necessary to “take inventory” of what was on the market. This was accomplished by establishing device panels for the various medical specialties composed of experts familiar with the devices areas who compiled a generic device list for their specialty areas. Each device was classified according to its hazard potential and existing data related to safety and effectiveness.

Medical device design and control in the hospital

2020 ◽  
pp. 436-445
Author(s):  
Jay W. Hall ◽  
Pamela Y. Shuck ◽  
Joel R. Canlas
Keyword(s):  
Medical Device ◽  
Device Design ◽  
Medical Device Design ◽  
And Control
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