scholarly journals Comparison of approval procedures for medical devices in Europe and the USA

2019 ◽  
Vol 5 (1) ◽  
pp. 605-608
Author(s):  
Marcel Vila Wagner ◽  
Thomas Schanze
Keyword(s):  
Life Expectancy ◽  
Medical Devices ◽  
Technical Equipment ◽  
The European Union ◽  
High Quality ◽  
Us Government ◽  
The Usa ◽  
Quality Of Products ◽  
Global Harmonization

AbstractImportant achievements such as the discovery of penicillin increased life expectancy in the 19th century. At the beginning of the 20th century, the influence of technical equipment and biomedical research led to a further leap in life expectancy. The use of computer devices with sophisticated software also improved the quality of life. This is linked to the fact that all these achievements have now led to the emergence of one of the largest import and export markets in the USA, alongside the european union (EU), which is an association of European states. In order to guarantee a uniform quality of this abundance of different products and therapies, there are worldwide corresponding regulations, to which all manufacturers must adhere. The entry into force of these regulations, with the associated approval and testing obligations for each individual medical device, ensures that a consistently high quality of products is used on patients. Of course, high quality as well as high functionality and safety levels of medical products are a must. However, the implementation of these regulations is realized differently in the various markets, as there is no global harmonization. This work focuses on approval procedures for medical devices in Europe (EU) and the USA and compares significant differences in the approval procedures, which are shown as a graphical comparison. An example is an approval of medical devices by the U.S. Food and Drug Administration (FDA), which is an US government agency. In Europe (EU) there is a manufacturer’s declaration of conformity for the approval.

scholarly journals Quality characteristics of spatial furniture

2009 ◽  
pp. 135-145 ◽  
Author(s):  
Dusan Skakic ◽  
Igor Dzincic
Keyword(s):  
Quality Control ◽  
Quality Characteristics ◽  
High Quality ◽  
Production Economy ◽  
Production Practice ◽  
Basic Quality ◽  
Quality Of Products ◽  
Quality Production

The quality of products represents one of the key aims of any modern organized production. In the production practice, it is essential to establish the optimal relationship between quality, production economy and delivery deadlines. Furniture quality is evaluated by three levels and they are: basic quality, high quality and especially high quality. The results presented in this paper are based on the sample measurements of chairs and tables during 2007 and 2008 at the Institute for Furniture Quality Control.

scholarly journals Features of Non-Tariff Regulation of Construction Products Market in Ukraine

2019 ◽  
Vol 8 (4S) ◽  
pp. 15-19
Keyword(s):  
Construction Industry ◽  
Health And Safety ◽  
Legal Framework ◽  
State Regulation ◽  
Market Regulation ◽  
The European Union ◽  
National System ◽  
Construction Products ◽  
Quality Of Products

The article deals with the issue of state regulation over the construction products industry. Analysis resulted in the identification of two main forms of regulation: tariff and non-tariff regulation. Global practices show the effectiveness of non-tariff regulation in the construction industry. Being a WTO member, Ukraine has to implement the legal framework of non-tariff regulation, in regards to those aspects contributing to compliance with the rating and standards of the European Union to ensure the quality of products. The main objective of non-tariff market regulation is to ensure the quality of finished products, environmental protection, health and safety of life. The national system of regulation, including technical rate-setting of the construction products manufacturing must comply with the international documents ratified by Ukraine. The article analyzes the domestic legal framework and proposes an algorithm for designing a national system of non-tariff regulation in accordance with international rules and standards.

scholarly journals Directions for Improving the Quality of Products of PJSC «Beer and Non-Alcoholic Plant «Radomyshl»

2020 ◽  
Vol 10 (513) ◽  
pp. 197-203
Author(s):  
O. I. Garafonova ◽  
◽  
I. F. Nechai ◽  
Keyword(s):  
Product Quality ◽  
Product Life Cycle ◽  
Quality Parameters ◽  
Quality Level ◽  
Business Organization ◽  
High Quality ◽  
The World ◽  
Developing Directions ◽  
Quality Of Products

In the world, product quality has long been one of the major instruments for ensuring the economic development of companies. Achieving high quality parameters, in turn, is an important part of the economic strategy of any success-oriented business organization. The article is aimed at developing directions for improving products of PJSC «Beer and Non-Alcoholic Plant «Radomyshl». The object of the research is the quality of beer produced by PJSC «Beer and Non-Alcoholic Plant «Radomyshl». The assessment of the quality level of the selected product in accordance with the requirements of DSTU 3888:2015 was carried out using the following groups of indicators: microbiological, organoleptic and physic-chemical. The process of assessing the product quality parameters is presented, which consists of seven consecutive stages and is carried out throughout the product life cycle. The factors under the influence of which the quality of products are formed and which may cause deviation from the specified quality parameters are analyzed and structured. The defects that appear due to these factors have been identified. The basis for improving the quality of products is primarily a thorough study of changes in demand for the business organization products. Three groups of measures are singled out, with the help of which one can achieve the desired level of product quality, namely: technological, organizational and socio-economic. A complex of priority measures to improve the quality of products of PJSC «Beer and Non-Alcoholic Plant «Radomyshl» is proposed. The element of scientific novelty is the development of an algorithm for the implementation of measures to improve the quality of products. During the implementation of measures to improve the quality, it is necessary to carry out systematic monitoring and generate reports on the implementation of the project in order to make possible an adjustment of the final result.

scholarly journals Сompetence development diagnostics in the process of music teachers training: European Union states and Ukraine experience

2017 ◽  
pp. 39-45
Author(s):  
O. О. Matveeva
Keyword(s):  
European Union ◽  
Music Teachers ◽  
Diagnostic Tools ◽  
Federal Republic Of Germany ◽  
The European Union ◽  
Arts Teachers ◽  
The Usa ◽  
Key Competencies ◽  
Teachers Training

The article deals with the analysis of tools used for competence development diagnostics in the European Union states (Federal Republic of Germany, Austria, Switzerland), the USA and Ukraine. The common approaches to the development and implementation of diagnostic tools in the process of music teachers training are determined: the competence-oriented educational standards and a complex of key competencies served as the basis for the diagnostic tools development; the development of diagnostic tools is carried out by Ministries, institutes and pedagogical and psychological laboratories; it is asserted that to provide education of high quality both psychological and pedagogical diagnostics are to be carried out. The author’s interpretation of terms used to define Musical Arts teachers’ general professional and specialized professional competencies and diagnostic tools providing for determining future specialists’ quality of education is offered.

scholarly journals Bridging the gap between geographic concept and the data we have: The case of labor markets in the USA

2020 ◽  
Vol 52 (7) ◽  
pp. 1395-1414
Author(s):  
Christopher S Fowler ◽  
Leif Jensen
Keyword(s):  
Labor Market ◽  
Labor Markets ◽  
Research Question ◽  
High Quality ◽  
Regional Bias ◽  
Regional Variations ◽  
Research Outcomes ◽  
The Usa ◽  
Over Time

A broad literature has made it clear that geographic units must be selected with care or they are likely to introduce error and uncertainty into results. Nevertheless, researchers often use data “off the shelf” with the implicit assumptions that their observations are consistent with the geographical concept relevant for their research question, and that they are of uniformly high quality in capturing this geographic identity. In this paper, we consider the geographical concept of “labor market” and offer a template for both clarifying its meaning for research and testing the suitability of extant labor-market delineations. We establish a set of metrics for comparing the quality of existing labor-market delineations with respect to the diverse meanings that researchers apply to the concept. Using the fit metrics established here, researchers can explore how delineations vary geographically, how they vary over time, and how this variation may shape research outcomes. Our assessment is that the quality of the extant delineations is relatively high overall. However, we find that different delineations vary significantly in the types of labor markets they represent, and that regional variations in fit within any given delineation may introduce noise or regional bias that merits consideration in any analysis conducted with these units. More broadly, the kinds of metrics we propose here have applicability for many other geographic entities where boundaries and scale can be only imperfectly defined.

scholarly journals Kaizen as a Method of Management Improvement in Small Production Companies

2015 ◽  
Vol 16 (2) ◽  
pp. 157-170 ◽  
Author(s):  
Barbara Kamińska
Keyword(s):  
Quality Management ◽  
Small Firms ◽  
Point Of View ◽  
Inexpensive Method ◽  
High Quality ◽  
High Position ◽  
Small Production ◽  
Quality Of Products ◽  
Management Improvement

Abstract„Quality is not everything but everything is nothing without quality”. The famous quotation from K. Ishikawa brings to our attention the fact that nowadays quality is one of strategic concepts from the point of view of functioning of companies, especially production-oriented ones. The lack of quality often eliminates a product from the basket of potential further choices. That means that quality is a prerequisite in the contemporary, highly competitive and saturated market. In order to ensure quality, enterprises introduce various concepts and methods to support quality management. They include, among others, the kaizen philosophy, which allows to minimize unnecessary actions (losses). It is especially recommended to small firms as an inexpensive method assuring high quality of products because they are constantly improved, which, in turn, guarantees maintaining a high position among competitors. This article aims to introduce the concept of kaizen by describing how it works and considering whether it can be successful in Polish companies.

Research and Development of High-Quality Mechanical Engineering Products

2013 ◽  
Vol 329 ◽  
pp. 503-506
Author(s):  
Zhe Wen ◽  
Qian Dong
Keyword(s):  
Research And Development ◽  
Market Research ◽  
Decisive Role ◽  
Structure Design ◽  
High Tech ◽  
High Quality ◽  
Core Components ◽  
Software And Hardware ◽  
Quality Of Products

Computer is high-tech equipment in the age of information, and has been widely applied in all industries by relying on its sharing, universality, intelligence and other characteristics. Seen from the structural composition, software and hardware are two core components of computer, and play a decisive role in the quality of computer and its system in the actual work. Software development is a process for building up software system or software of system according to the needs of users; in high-quality software research and development, multiple aspects such as market research, demand analysis, structure design and model debugging are involved, and the quality of products can be ensured only if each operation link is strictly controlled.

scholarly journals Development and characterization of biodegradable compound based on EPDM and wood waste

2020 ◽  
Author(s):  
Mihaela Nituica ◽  
Laurentia Alexandrescu ◽  
Mihai Georgescu ◽  
Maria Sonmez ◽  
Maria Daniela Stelescu ◽  
...  
Keyword(s):  
Point Of View ◽  
Wood Waste ◽  
The European Union ◽  
Economic Agents ◽  
Antibacterial Compound ◽  
Ft Ir ◽  
Quality Of Products ◽  
Polymeric Waste

In the European Union, the potential for recycling technological and post-consumer polymeric waste is untapped. Their recycling and reuse are very low, compared to other types of waste such as glass, paper, etc., and the rates of storage, even of incineration, is very high in terms of percentage. Therefore, by reusing them, but also making use of new advanced technologies, we can contribute to improving the quality of products, and to environmental protection by recycling waste, protecting human health by eliminating toxins during their incineration, but also increasing turnover for global economic agents. Thus, this paper presents the obtaining and characterization of an antibacterial compound based on EPDM elastomer and wood waste (sawdust). The antibacterial compound is characterized from a physical-mechanical and structural point of view (FT-IR), all according to standards in force.

scholarly journals Integrated Quality-Based Production-Distribution Planning in Two-Echelon Supply Chains

2021 ◽  
Vol 2021 ◽  
pp. 1-10
Author(s):  
Husein Pasha ◽  
Isa Nakhai Kamalabadi ◽  
Alireza Eydi
Keyword(s):  
Mixed Integer ◽  
High Quality ◽  
Swarm Optimization ◽  
Integrated Production ◽  
Quality Degradation ◽  
Production Distribution ◽  
Quality Of Products ◽  
Over Time

The integrated production-distribution (P-D) planning has turned into one of the most essential areas in supply chain (SC) management in recent years, especially in the case of perishable products in which the quality of products can change over time. Nonetheless, so far, the suggested models have focused on the P-D stages of the chain while the delivery of high-quality products to customers is of paramount significance in the perishable SC. In the present paper, a multiobjective, mixed-integer, and nonlinear programming (MOMINLP) mathematical model was developed for integrated P-D deteriorating items in a two-echelon SC that emphasizes quality degradation. Quality is monitored and calculated as a function of temperature and time throughout the SC, and the main purpose of the model is to first increase the quality of products delivered to customers and, second, minimize the SC costs. To optimize the problem, the particle swarm optimization (PSO) approach was also incorporated into the model. The obtained model was applied to a case study in Protein Gostar Sina Company in Iran, which resulted in decreased P-D costs as well as increased customer satisfaction.

scholarly journals STUDY OF ROAD AND STREET HORIZONTAL MARKING REFLECTIVITY

2020 ◽  
Vol 12 (0) ◽  
pp. 1-5
Author(s):  
Ignas Vasiliauskas ◽  
Audrius Vaitkus
Keyword(s):  
Traffic Safety ◽  
Research Work ◽  
Scientific Work ◽  
Legal Regulation ◽  
Road Maintenance ◽  
The European Union ◽  
Traffic Conditions ◽  
The Usa ◽  
Road Marking

The article describes the change in the reflection of the horizontal sign examined in the scientific work taking into account the factors of road maintenance and traffic intensity. Methods applied in accordance with the standards in force in the European Union. In order to carry out the study in a smooth way, the scientific work analyzes the horizontal amount of road marking materials, types of markings, the change of reflection in the main traffic conditions. The current legal regulation of Lithuania and other European countries, the USA is also reviewed. “The research work also develops the topic of the effectiveness of the methodology of maintenance and renewal of horizontal road markings abroad and in the Republic of Lithuania.” Recommendations are provided on how to improve the quality of horizontal road marking maintenance. Analyzes of national legislation on horizontal vehicle signs, recommendations on how to improve them to ensure the quality of the production of larger horizontal signs, or the best traffic conditions for all road users. Evaluating the reflectivity of selected streets in dry and wet conditions, making suggestions on how to improve the horizontal reflections of road markings and, at the same time, traffic safety.

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