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Creation and application of the system of financial evaluation
ŽIVNÁ, Zuzana
The aim of this bachelor thesis is the creation of a system of financial evaluation for the company GN Hearing Czech Republic spol. s r.o., which is an importer of hearing aids, also providing services. This company belongs to GN Group, a global company from Denmark. The data source is the annual financial statements from 2015 to 2020. The methods used in this thesis are horizontal and vertical analysis, ratio (profitability, activity, leverage, liquidity ratios), Du Pont, credibility and bankruptcy models. These methods have been adapted to the specifics of the company. One of these specifics is that medical devices are affected by price regulation, which prevents the increase of margin. This is reflected in the profitability evaluation system. This paper uses a comparison of the results of the financial analysis with companies that also sell hearing aids on the Czech market. Based on the created system, possible changes for improvement are proposed.
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Medical devices regulatory framework
Honegr, Jan ; Staša, Josef (advisor) ; Vedral, Josef (referee)
Charles University in Prague, Faculty of Law Department of Administrative law Candidate: PharmDr. Jan Honegr, Ph.D. Supervisor: JUDr. Ing. Josef Staša, CSc. Title of diploma thesis: Medical devices regulatory framework The subject of this diploma thesis is the regulatory framework for the so-called "general" medical devices with a slight overlap in the field of in-vitro medical devices. The presented work aims to describe the impact of the planned change in the regulatory framework for medical devices on economic operators in the field of production and distribution of medical devices in the Czech Republic. In this work I gradually deal with the historical development of the regulatory framework for goods in the European Communities and subsequently the European Union and the specific regulation of for medical devices. I deal in detail with the multilevel regulatory framework and the relationships between its components. I focus in more detail on the key change in the regulatory framework, which is represented by the hitherto ineffective EU Medical Devices Regulation 2017/745 and government bills to prepare the Czech legal system for the adoption of this directly effective European Union legislation. The main parts of the work are chapters 5 and 6 in which, I deal with the potential impacts of the...
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Free Movement of Medical Devices
Moravová, Veronika ; Šmejkal, Václav (advisor) ; Svoboda, Pavel (referee)
1 Abstract This thesis deals with the conflict between the interest in the free movement of medical devices and the interest in the protection of health and safety. It is divided into two main parts, with the first part focusing on the pre-market phase, i.e. the phase before a medical device is placed on the market. The first part consists of two chapters describing the historical development of the regulation of medical devices and its separation from the regulation of medicinal products, as well as the way in which medical devices enter the market and what they must fulfil in order to be freely traded across the Member States. In particular, this part addresses the question of whether this separation (i.e. the move away from the 'old approach' to the 'new approach') was a step in the right direction or a 'historical mistake'. The system of CE certification of medical devices based on the participation of external auditors - Notified Bodies - is thoroughly discussed. The second part of the paper is devoted to the post-market phase (after the medical device has been placed on the market). The focus is on two 'knot problems', i.e. areas where the interest in free movement and the interest in protecting health and safety collide in practice, namely border products and parallel trade (specifically issues...
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Medical remedies
Matěvosova, Elena ; Rajchl, Jiří (advisor) ; Svoboda, Petr (referee)
Medical devices Abstract The subject of this master thesis is the issue of medical devices. This thesis focuses on its reimbursement regulation. The work is divided into six chapters. The introductory explanation is devoted to the concept of medical device and it analyzes both the European definition of medical device and the national legal definition. The next part of the chapter emphasizes various division of these products, namely its variants, types and also classification of medical devices according to risk classes. The second chapter describes legal sources. The attention is paid to international sources of law, then furthermore to European law, from current directives to new regulations, which will come into force in 2020. In this chapter is generally discussed what changes this new regulations bring, as it is further elaborated in the next chapter. Last but not least, the national sources of law are analyzed. The legal regulation enriched by the outline of the future legal regulation awaiting the area of medical devices is widely mentioned. The next chapter defines institutions. The Ministry of Health and the State Institute for Drug Control are the key institutions in the field of medical devices, however, they are not the only authorities to carry out state administration in the field of medical...
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Application of the Balanced Scorecard in the company ELLA-CS
Cwierz, Jan ; Neumaierová, Inka (advisor) ; Beneš, Oldřich (referee)
Balanced Scorecard belongs to the most prominent managerial tools for performance measurement and strategy management. Aim of this thesis is to describe BSC with emphasis to small and medium enterprises using literature review. Additional supporting tools for strategy formulation are included as well. BSC is then proposed for implementation in privately owned small enterprise in the sector of medical devices. Based on the thorough analysis of the company and its environmental factors operational and strategical performance gaps are identified. Such gaps are then addressed by means of BSC including financial, customer, internal processes and learning and growth perspective. Despite some limitations inherent to SMEs in general introduction of BSC is feasible and could be of value to all company stakeholders.
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Regulation of launching medical devices onto the market
Litavský, Ondřej ; Vavrečka, Jan (advisor) ; Štěpánek, Petr (referee)
This diploma thesis deals with the topic concerning regulation of launching medical devices onto the market with regard to the analysis of key regulatory framework. The aim of the thesis is to find out if the legal framework really fulfils its de lege ferenda objectives. The purpose of this thesis is to confirm or disprove a hypothesis that the regulation of launching medical devices onto the market is sufficient and effective from the point of view of consumer protection and interests of other stakeholders. Secondary aim of this diploma thesis is to confirm or disprove a hypothesis that the harmonization of legal framework in the EU is appropriate and effective. These hypothesis are to a certain extent following up the verification of four essential goals that should be reached by the regulation. One of the key aims is assuring the safety of the products, enabling them to move freely in terms of the internal market of the EU and assuring that the consumer isn't misled when deciding about his optimal situation. Besides that the regulation shouldn't unnecessarily slow down the activities of businesses and inappropriately limit their innovation potential. The diploma thesis has a critical point of view concerning some aspects of this regulation and in the end the author suggests some proposals in order to improve the current practice.
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Zavedení nového postupu zdravotní péče pro český trh
Havran, Adam ; Lhotáková, Markéta (advisor) ; Cook, Gina (referee)
The objective of this work is to analyse the possibility of use of micro -- needles technology as the method of drug delivery in the Czech Republic. The characteristics of this product (application, connection with drug, etc.) suggest three possible target groups: patients, health care providers or pharmaceutical companies. One of the goals is to analyse legal requirements on such products, evaluate current market situation and according to this information choose the best group for the product consumption. Also product itself presents a challenge and there are several designs of micro -- needle or needleless drug applicators. Combined together, this study aims to find, whether is the Czech market able to accept new method of drug delivery, in which form and how can patient reach this technology.
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Demarcation between the categories of products with physiological function on human body in EU law
Vavrečka, Jan ; Švarc, Zbyněk (advisor) ; Boháček, Martin (referee) ; Jakl, Ladislav (referee)
The thesis is focused on theoretical principles of demarcation of products with health effects in the EU law and on the reflection of these issues in the application and administrative practice in commercial law. The thesis developed yet been brought judicial interpretation with the scientific interpretation of certain key and decisive problems that separate from each other law-regimes of regulation: medicinal product for human use, foods, cosmetics products, medical devices and biocides. Correct law-regime for a particular product is determinating of the general legal basis in the EU internal market. It is therefore a important problem not only in EU law, but also in EU economic. Thesis results are highly critical of current practice in the local markets of EU member states, especially Czech Republic, and in many instances documented sub-optimal application of this law in general practice.
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