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The System of Process Audits for Medical Industry
Pokorná, Klára ; Moravcová, Zdeňka (referee) ; Bartes, František (advisor)
The Master’s thesis deals with the area of conducting process audits in a large multinational corporation focused on manufacturing and distribution of medical devices, which has a subsidiary in the Czech Republic. The thesis discusses the analysis of the current set up of the internal audits‘ system in the corporation and there are changes of the quality system being proposed on the basis of the analysis, whose aim is to achieve a full compliance with the requirements of the US administration FDA, the standard ISO 13485 as well as the recent requirements on performing process audits. The emphasis is also put on the setting of the system such that it provides the highest possible added value for its users, can be easily implemented in practice and is flexible as well.
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Launching medical devices on the market
Dvořáková, Jitka ; Svoboda, Petr (advisor) ; Millerová, Ivana (referee)
The issue of launching medical devices on the market became more intense in the last few decades in connection to the expansion of the pharmaceutical industry and legal area. This legal area is still mostly undescribed and it stands in the shadow of known and more discussed medical products. Proper legal theoretical analysis is often completely absent. This master thesis aims to complexly describe and analyse theoretical bases of current legislative regulating the launching of the medical devices on the market, including other processes related to this issue. Emphasis is places on the concept of medical device, the responsibility of the manufacturer and the nature of notified body. The author focuses on the subsequent conformity assessment process and process of registration. The process of notification and exemption from this obligation and administrative nature of selected documents. The thesis is divided into eleven chapters and the introductory chapter focuses on a general introduction to the field of pharmaceutical law, namely the regulation of medical devices, including the definition of basic questions in the work under study. The second chapter deals with the analysis of sources of legal regulation of medical devices. The chapter is divided into sources of the law of the Czech Republic and...
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Maintenance, care and control of ambulance car equipment from the view of paramedic
ŠTOLBA, Jan
Paramedics use, as part of their work, their own potential, for example knowledge, experience and skill. They must also be able to deal with medical devices and medical instruments, they have to know how to use them and also how to control them and maintain them. This thesis focuses on the area of control, care and maintenance carried out by paramedics on medical devices. Further specification of these activities is not appropriately analyzed in current literature. Only legal sources, technical standards or user manuals of individual medical devices are available. Activities in relation to the care, maintenance, and control of medical devices in particular, are major part of paramedic workload prior to the emergency medical services itself. Each paramedic should have a precise idea of how to treat particular medical device, maintain it and service it. Bachelor thesis therefore aims to define and map the extent of the activities of paramedics during the performance of maintenance tasks, control and care of medical equipment of EMS vehicles, while it also wants to highlight the risks associated with the performance of these activities. Through the comparison of available resources, activities in connection with the performance of control operations, maintenance and care executed by paramedics on specific medical devices and equipment EMS vehicle were mapped. These activities are then described in individual sections of this thesis. The research was carried out as a survey with sample of 91 respondents, paramedic students, and interviews with paramedics and emergency medical services personnel in Ústí nad Labem and South Bohemia Region. To ensure the goal of this thesis, time range, frequency, and frequency of individual tasks and activities related to maintenance, inspection and care of medical equipment were determined. I see the main contribution of this thesis in specifying the activities and operations of control, care and maintenance of medical devices used every day by paramedics of emergency medical service. Based on my own experience I know that for student purposes there are no guidelines or document illustrating the performance range of activities of control, care and maintenance carried out by paramedics on medical devices. From my position as a paramedic student I perceive the inaccessibility of any comprehensive manual for this area rather negatively. Based on this, I have approached the bachelor thesis in the way, so that it can be the basis or foundation for the creation of this manual, or possibly to become such a simple manual itself. As a future paramedic I think it is important that the education of paramedic students is sufficient and complete to the extent that, when taking into practice paramedic will be a full member of the medical crew in the vehicle of emergency medical services.
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The System of Process Audits for Medical Industry
Pokorná, Klára ; Moravcová, Zdeňka (referee) ; Bartes, František (advisor)
The Master’s thesis deals with the area of conducting process audits in a large multinational corporation focused on manufacturing and distribution of medical devices, which has a subsidiary in the Czech Republic. The thesis discusses the analysis of the current set up of the internal audits‘ system in the corporation and there are changes of the quality system being proposed on the basis of the analysis, whose aim is to achieve a full compliance with the requirements of the US administration FDA, the standard ISO 13485 as well as the recent requirements on performing process audits. The emphasis is also put on the setting of the system such that it provides the highest possible added value for its users, can be easily implemented in practice and is flexible as well.
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Inventories in a company with business activities
Motlová, Eva ; Müllerová, Libuše (advisor) ; Janhubová, Jaroslava (referee)
The thesis deals with the issue of inventories in a company with business activities. The aim of the thesis is at first theoretically to introduce the accounting of inventories and then to demonstrate the accounting activities on a real company. The practical part of the thesis focuses on a company that sells medical devices. Due to the choice of company and its business activities this thesis highlights the general and specific information about business with medical devices and the areas connected to this.
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Import of medical divices to the European Union
Mrkvová, Kateřina ; Švarc, Zbyněk (advisor) ; Koucká, Jiřina (referee)
The theses is regarding at the beginning the theoretical conception of joint trading policy and tariff union, esspecially law regulations concerning with an import form third countries. As a kind of change-over of acts is an implementation of these law regulations, acting as a connected point between these regulations and theirs application. The practic sample of import of the medical device is based on the mentioned regulations with the attaching of the principles for an international purchase contract and the other juridical institutes which are regarding the case in several details. At the end of the case is enclosed also the sample of delivery of the imported goods to one of European countries as an example of intracommunitary performance.
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Introduction of new product to the market
Horáčková, Andrea ; Boučková, Jana (advisor) ; Mohelská, Hana (referee)
This Master's Thesis deals with the introduction of the new type of contact lenses ACUVUE to the Czech market. The thesis is divided into three parts. The first is focused on theoretical analysis of the standard procedure for introducing of new products to the market which is possible to find in professional publications. The practical part analyses the introduction procedure of new ACUVUE contact lenses in Vision Care Division of Johnson & Johnson company. Final part of this thesis includes evaluation of the Vision Care marketing strategy and recommendations which can improve the introducing procedure for the future. The required outcome of this work is the evaluation of the analysis and set a few recommendation for improvement of the introduction process for the future.
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Medical instrument for purposes of application of value added tax
Hylská, Ludmila ; Svátková, Slavomíra (advisor) ; Svátková, Slavomíra (referee)
A product or goods that gained status of a medical instrument is burdened with lower value added tax (VAT). In such cases, conflict of interests among producers and government comes into being. The interest of producers is to gain the status of medical instrument for their products. On the other hand, the interest of government is to lower the hazards with human health. The first part of the paper deals with definition of medical instrument and its technical requirements. Especially, it deals with general requirements in design, construction and labeling of medical instruments. The second part of the paper deals with clinical tests processing analysis and clinical evaluation and the description of subjects involved in gaining the status of medical instrument. The aim of the paper is to evaluate regulations in gaining the medical instrument status.
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