DIN EN ISO 13485 - QM for medical devices in the plastics industry

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 implement, maintain and improve a management system in accordance with ISO 13485 in the plastics industry.

Content:

• Medical Devices Act
• European Directives and Medical Device Regulation
• Marketing of medical devices
• Requirements according to DIN EN ISO 13485
• Connection to DIN EN ISO 9001
• Implementation of the required documentation
• Basics of risk management
• Practical examples from the plastics industry, field reports
  
  

Practice:

• Documentation requirements in practice
• Working environment: maintenance and servicing of machines
• Working environment: Cleaning machines
• Biocompatibility of cleaning agents and lubricants
• Qualification of production facilities
• Validation of production processes
• Change/risk management in practice

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