SIQ: Online training course: EN ISO 13485:2016 – Quality Management System for the Medical Devices Industry – Basics

This workshop will be in English and is part of our academy cooperation with the Slowenian notified body SIQ!

About the training

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.

Costs

• Standard: 475,00 EUR (excl. VAT)
• Get your special 10 % en.co.tec-discount with this code: encosiq10
  
• incl. seminar documents as PDF and a certificate of participation.

Your Trainer

Marjetka Kralj Kunčič PhD is a Doctor of Science in microbiology with more than 17 years of experience in quality management systems. Her previous work with a medical device manufacturer included not only laboratory management and quality control, but also active involvement in the development, production and regulatory compliance of medical devices, as well as quality management system compliance. Currently, she works as an SIQ auditor and a consultant in the field of medical devices and a member of the technical group for the preparation of health protection standards.PhD

Location: ONLINE

The online workshop will take place in a live online e-classroom. Up to two days before the implementation, registered participants will receive a link to the online training. Participants need a computer with a microphone and a camera, as well as access to a reliably functioning internet connection to participate in online training without interruption.