The course will present the requirements of the EN ISO 13485:2016 standard for the quality management system in the production of medical devices (and related services) and related legislation applicable to the field of medical devices.
Medical devices placed on the market must comply with the Regulation (EU) 2017/745, which applies to each individual product of a particular type or model and it has in certain areas has a significant impact on both the QMS and the devices themselves.
The basic purpose of the standards is to facilitate the harmonization of legal requirements applicable to this area. In the course you will gain knowledge that will help you in:
establishing and / or maintaining a quality management system,
preparation of documentation or technical files for medical devices,
obtaining the CE certificate for medical devices,
effective implementation of internal audits.
Review of the requirements of EN ISO 13485: 2016; Medical devices - Quality management system - Requirements for legislative purposes
Comparison with ISO 9001 requirements, with emphasis on specific requirements for development, infrastructure and working environment, traceability, and reporting
Familiarization with the requirements of the medical directive and the activities necessary to meet the requirements
At the end of this course, participants will be able to:
Understand the requirements of ISO13485:2016 for medical products and related services
Ensure an efficient and successful medical device quality management system transition to improve and maintain compliance
Acquire the skills to take on the position of Internal Medical Services Auditor in their company
Uroš Tacar has more than 25 years of experience in medical devices and in the field of development and legislation. He participated in the establishment of the quality system and in ensuring the compliance of active medical devices. At the manufacturer, he performed the duties of development manager and representative of the quality management. Among the most important tasks, he led the production and maintenance of technical folders of medical devices. He is a consultant and works at SIQ as a lecturer and long-term assessor in the field of medical devices.
The online course will take place in a live online e-classroom. The day will be divided into three parts with breaks in between. Up to two days before the course, registered participants will receive a link to the online course. Participants will need a computer with a microphone and camera and access to a reliable working internet connection to participate.
Main steps in the process of obtaining the CE mark and more about certification procedure according to Regulation (EU) 2017/745 and ISO 13485 you can find HERE.