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Online training course: 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

  • Participants will learn about the basic requirements of the standard for a quality management system. The focus is on learning the scope and aim of the standard and the basic requirements that a manufacturer must meet.
  • With the knowledge gained, participants will be able to follow more advanced topics such as internal auditor activities, risk management processes, software lifecycle management, and other topics related to medical device manufacturing.

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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