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24. 07. 2024 (execution guaranteed)
Online training course: EN ISO 13485:2016 – Quality Management System for the Medical Devices Industry – Basics
| 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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Dates: 24. 07. 2024 (execution guaranteed)ID: 15525Please choose a dateRegistration
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Duration:
1 Day (09:00 - 15:00)
7 school hours - Lecturer: Dr. Marjetka Kralj Kunčič
- Number of vacancies: 13
- Registration fee: 475,00 EUR (does not include VAT)
Pay the registration fee no later than three days before the training, unless otherwise stated, to the account of SIQ Ljubljana SI56 02922-0012897988 opened with NLB, d.d. Reference: 15525.
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