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UID:69e4c2841acb8@leapup.bitshifters.cloud
DTSTAMP:20260419T135444Z
DTSTART:20251013T090000Z
DTEND:20251016T163000Z
SUMMARY:DIN EN ISO 13485 - QM for medical devices in the plastics industry
DESCRIPTION:In this course\, you will acquire comprehensive knowledge of a management system in accordance with DIN EN ISO 13485. You will be up to date with the latest national and European legislation. You will familiarise yourself with the additional requirements of DIN EN ISO 13485 compared to DIN EN ISO 9001. These relate in particular to documentation\, the development and monitoring of medical devices as well as traceability and validation of processes in the plastics industry. You will also deal with the basic requirements for risk management. With the help of practical examples from the plastics industry and group work\, you will acquire the most important knowledge of the standard and understand the individual general and legal requirements. You will be able to implement the legal requirements in your company. After this course\, you will be ready to introduce\, maintain and improve a management system in accordance with ISO 13485 in the plastics industry.Content:\n\nMedical Devices Act\nEuropean Directives and Medical Device Regulation\nMarketing of medical devices\nRequirements according to DIN EN ISO 13485\nConnection to DIN EN ISO 9001\nImplementation of the required documentation\nBasics of risk management\nPractical examples from the plastics industry\, field reports\n\nPractice:\n\nDocumentation requirements in practice\nWorking environment: maintenance and servicing of machines\nWorking environment: Cleaning machines\nBiocompatibility of cleaning agents and lubricants\nQualification of production facilities\nValidation of production processes\nChange/risk management in practice\n\nFor more information on the event click here.
LOCATION:SKZ – Das Kunststoff-Zentrum\, Friedrich-Bergius-Ring 21\, 97076 Würzburg
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