Safety models: an analytical tool for risk analysis of medical device systems

2002 ◽  
Author(s):  
K. Sayre ◽  
J. Kenner ◽  
P.L. Jones
Keyword(s):  
Risk Analysis ◽  
Medical Device ◽  
Analytical Tool ◽  
Safety Models

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.

scholarly journals ANALYSIS OF FACTORS AFFECTING GENERAL SUPPLIERS TO SELL FFB WITH A AND B QUALITY TO PT. SANDABI INDAH LESTARI AND RISK ANALYSIS OF THE RESOURCES

2019 ◽  
Vol 2 (1) ◽  
pp. 1-12
Author(s):  
Ali Setia Iskandar ◽  
Yuwana Yuwana ◽  
Bambang Sumantri
Keyword(s):  
Regression Analysis ◽  
Risk Analysis ◽  
Linear Regression Analysis ◽  
Multiple Linear Regression Analysis ◽  
Analytical Tool ◽  
Fresh Fruit ◽  
Factors Affecting ◽  
Long Period ◽  
Average Factor ◽  
Fresh Fruit Bunches

This study studies to analyze the factors that influence general suppliers to choose FFB (Fresh Fruit Bunches) on quality and quality B and calculate the business expenses to be received. This research was conducted in the period August - September 2018 at PT. Sandabi Indah Lestari (SIL). The analytical tool used in this study is multiple linear regression analysis and risk analysis. Based on the results of the analysis, the factors that influence general suppliers choose to sell FFB at quality A and quality B at PT. SIL is the average factor of the weight of FFB supplied, the weight of FFB sorted, the distance to the plant and transportation costs, while the factors that do not significantly affect the long period of receiving FFB at the plant then for the risks received are known that the risk of selling FFB quality A is greater because of loss while FFB that sells quality B is smaller because it avoids losses.Keyword: Suppliers, FFB (Fresh Fruit Bunches), quality A and B, risk

scholarly journals Clinical risk evaluation of medical device software: an axiomatic design-based methodology

2019 ◽  
Vol 301 ◽  
pp. 00005
Author(s):  
Fernando Rolli ◽  
Fabrizio Pecoraro ◽  
Daniela Luzi ◽  
Fabrizio L. Ricci ◽  
Elaheh Pourabbas ◽  
...  
Keyword(s):  
Risk Analysis ◽  
Medical Device ◽  
Axiomatic Design ◽  
Management Plan ◽  
Software Application ◽  
Safety Issues ◽  
Function Points ◽  
Clinical Risk ◽  
Medical Device Software ◽  
Definition Of

The increasing complexity of medical device (MD) management software requires the adoption of new methodological approaches that pay particular attention to safety issues. The risk analysis is one of the key activities to be carried out by the manufacturer before the development of the software application as it determines the type of documentation to be provided as well as the activities to be performed to place the MD on the market. After the definition of software requirements and their iterative transformation into architectural items and/or units, the manufacturer defines the safety class of each item. The adoption of an axiomatic design approach facilitates this process. This combination of techniques helps to focus the design of medical device software on non-conformities with a clear link to clinical risk. This objective can be achieved by assessing the complexity of the system to be designed, both in terms of its functional size, and as a level of overall clinical risk. In this multi-dimensional perspective, the software effort expressed in function points provides an estimate of the development cost. While the clinical risk analysis allows to quickly identify critical areas, to intervene with the same promptness and to draft a management plan according to the regulations of the various control authorities.

scholarly journals Medical Device Safety Management Using Cybersecurity Risk Analysis

IEEE Access ◽  
2020 ◽  
Vol 8 ◽  
pp. 115370-115382 ◽  
Author(s):  
Dong-Won Kim ◽  
Jin-Young Choi ◽  
Keun-Hee Han
Keyword(s):  
Risk Analysis ◽  
Medical Device ◽  
Safety Management ◽  
Medical Device Safety

scholarly journals Intellectual risk analysis methods.

2020 ◽  
Vol 11 (8-2020) ◽  
pp. 165-171
Author(s):  
D.S. Chereshkin ◽  
◽  
G.V. Royzenson ◽  
V.B. Britkov ◽  
◽  
...  
Keyword(s):  
Risk Analysis ◽  
Human Factor ◽  
Measurement Methods ◽  
Analytical Tool ◽  
Economic Systems ◽  
Engineering Model ◽  
Analysis Methods

The paper proposes a scheme for constructing a multidimensional classifier of risk analysis methods. The proposed multidimensional classifier of intellectual methods of risk analysis can be considered as a convenient analytical tool, because allows you to identify "gaps" in the development of these methods. Such an approach makes it possible for the selected specific tasks, taking into account the properties of socio-economic systems (uniqueness, the presence of several poorly formalized goals at once, material difficulty for determining optimality, dynamism, multi-criteria, taking into account the human factor and the possibility of interpreting the result), as well as measurement methods risk (engineering, model, expert and sociological) indicate a list of already developed methods or methods, the development of which is a promising problem.

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