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Online workshop: EN ISO 13485:2016 – Quality Management System for the Medical Devices Industry – Basics
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| According to the legislation, the manufacturer of medical devices must establish a quality management system. The harmonised standard EN ISO 13485:2016, providing requirements specific to this field, has been established for that purpose. |
Aim
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Content
- Brief description of medical directive requirements and regulatory requirements
- Overview of the structure of the standard
- Overview of the scope and aim of the standard
- Overview of the basic requirements of the standard
- Overview of possible implementation methods (depending on the role of the organisation in the product manufacturing process)
Work method
- The e-training course will be held in a live virtual environment.
- Two days before the event, you will receive a web link to the e-mail address you provided at the registration.
- To participate in the online workshop, you will need a computer with a microphone and a camera and a reliable internet connection.
Target group.
- Anyone who wants to learn the basic requirements for a quality management system:
- Medical device manufacturers.
- Component manufacturers/service providers in medical device manufacturing processes.
- Medical software agents/suppliers.
- Management representatives.
 | You will receive a certificate of attendance upon completion of the online training course. |
| Don't miss the opportunity to gain a comprehensive insight into the Quality Management System for the medical devices industry according to EN ISO 13485:2016 basics. |
Additional information: Bojan Varga, phone: +386 1 477 81 08, e-mail: bojan.varga@siq.si
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