Aktualizace interní dokumentace související s vývojem zdravotnických prostředků.

Abstract

This bachelor thesis deals with quality management system in medical device manufacturing, the thesis focuses on design and development planning and related documentation. The aim of the thesis is to identify and update design and development documentation of the chosen organization in order to ensure compliance with the requirements of the ČSN EN ISO 13485:2016 standard, as well as to analyze the compliance of documentation control requirements with the same standard. The results of the comparative analysis highlighted the need to create the document “Handover Protocol” and to optimize the document “User/Product/Process Requirements”. Additionally, an analysis of document control is carried out. A process flowchart diagram is created to illustrate the generation of a document within the organization.The standard's requirements for document control are then compared with the organization's internal directive. Finally, several recommendations are provided to improve the efficiency of documentation management for design and development, as well as for document control.