Workshop: Basic of Regulation (EU) 2017/745 (MDR), ISO 13485, Technical Documentation and Clinical Evaluation

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 Quality Management System and the devices themselves. The purpose of workshop is to achieve or improve basic knowledge of the MDR and ISO 13485 requirements, present steps of technical documentation preparation and get to know the key elements of clinical research and evaluation.

LOCATION AND TIME
The online training will take place in a classroom setting at Tallinn Science and Business park (Teaduspargi 6/1, meeting room Merkuur). Each day will be divided into three parts with breaks in between.

Content description
• Interpretation of MDR and ISO 13485 requirements based on practical examples
• Structure of a medical device technical documentation
• Supporting documents and guidelines (Declaration of conformity, Classification of medical devices, Harmonized standards, Risk assessment documentation…)
• Key elements of clinical research and evaluation

Training performance and Certificate
The online workshop consists of lectures, practical examples, and exchange of views and experiences. Attendees gain the SIQ Certificate of participation.

Lecturer
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.

Tickets: Free for members and partners of The Connected Health Cluster, others can buy a ticket for 300€+km. The number of tickets is limited! If you have any additional questions, please contact connectedhealth@tehnopol.ee.

See you there!

The Connected Health Cluster led by Tehnopol Science and Business Park is Estonia’s biggest healthcare tech community, uniting health service providers, health tech companies and all other key interest groups in the field. The cluster’s support enables domestic cooperation projects and the export of health technological solutions to other countries. The activities of the cluster are co-financed by the European Regional Development Fund.