Uroš Tacar has more than 25 years of experience in medical devices and in the field of development and legislation. Acquire the skills to take on the position of Internal Medical Services Auditor in their company.Ensure an efficient and successful medical device quality management system transition to improve and maintain compliance.Understand the requirements of ISO13485:2016 for medical products and related services.Case study: recording of nonconformities and simulation of assessmentĪt the end of this course, participants will be able to:.Internal auditing – purpose, planning, preparation, implementation, reporting.Familiarization with the requirements of the medical directive and the activities necessary to meet the requirements.Comparison with ISO 9001 requirements, with emphasis on specific requirements for development, infrastructure and working environment, traceability, and reporting.Review of the requirements of EN ISO 13485: 2016 Medical devices – Quality management system – Requirements for legislative purposes.effective implementation of internal audits.obtaining the CE certificate for medical devices,.preparation of documentation or technical files for medical devices,.

establishing and / or maintaining a quality management system,.

In the course you will gain knowledge that will help you in: The basic purpose of the standards is to facilitate the harmonization of legal requirements applicable to this area. 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 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. Participants gain the IQNet Certificate ( Internationally Recognized Certificate) and SIQ Certificate showing successful completion of the course.Ĭourse and materials will be in English language. ISO 13485:2016 Medical Devices Quality Management Internal Auditor Training Course

Iso 13485 auditor training courses