|
|
Proposal of conformity assessment and inspection procedure of a cyllinder flange
Ondruška, Jan ; Jankových, Róbert (referee) ; Harčarík, Matej (advisor)
This bachelor thesis contains the control plan creation procedure for conformity assessment of a cylinder flange. The thesis includes a selection from standards related to the above-mentioned problems and the drawing documentation of the part. The cylinder flange is analysed in terms of function and unambiguous specification of geometry on the drawing of the part with regard to further part inspection. Any deficiencies in clarity are dealt with in more detail and solutions to these problems are proposed. Control plans for inspection of the part directly in the manufacturing process and for inspection of the part during sampling were created using CAQ software and are attached to the work. The results of the work have been used to improve the process of manufacturing of the part.
|
|
|
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...
|
|
|
Risk management in the testing laboratory
Virágová, Tereza ; Bednářová, Bronislava (referee) ; Vymazal, Tomáš (advisor)
This thesis is dealing with analyzing risks in an accredited testing labotarory. In this thesis will be made a search of available manuals and literature issued for accredited testing laboratory. In this thesis will be conducted selected analyzes for selected processes. The aim of this thesis is to analyze and asses the risks in chosen processes of testing laboratory and make a a simple tools for the management and elimination.
|
|
|
Legal Aspects and Practical Consequences of the Conformity Assessment - CE Conformity Marking
Cervanová, Iva ; Boháček, Martin (advisor) ; Vavrečka, Jan (referee)
The topic of my diploma thesis is removing the technical barriers of the trade of goods via harmonization of the essential requirements on the products -- mainly the legal aspects and practical consequences of the conformity assessment and the CE conformity marking. The goal of my thesis is firstly to find out what the main objective of the CE marking is and whether it really fulfills its role. Secondly, I want to find out how the process of conformity assessment looks like in practice. Thirdly I want to find out how the market surveillance is organized and how effective it is. My thesis is divided into six chapters. The first chapter depicts the situation as it had been before the marking was introducted. The second describes the statutory regulation of the CE marking system. The fourth chapter is dedicated to the process of the conformity assessment. The fifth chapter is about the market surveillance. The final sixth chapter explores problems that are related to the CE marking system.
|
|
|
Conformity assessment in commerce policy of EU countries
Kozlovská, Barbora ; Plášková, Alena (advisor) ; Skopal, Jaroslav (referee)
Difference between technical standards, legislation and certification and testing procedures in specific EU countries complicates unification of international markets. Therefore international standards and procedures for conformity assessment of products that are connected to Agreement on Technical Barriers to Trade have been created. Completion of all requirements, standards, procedures and marking, including proposals regarding resolving problematic areas, is the main content of this diploma thesis.
|
guest ::
