UDEM Trainings

PURPOSE: EN ISO 14971 Risk Management in Medical Devices Training helps define, assess, control risks in the life cycle of a product in medical devices and implement a risk management framework within the framework of continuous compliance.

The EN ISO 10993-1:2020 standard is a standard used in the medical device industry to ensure that products that come into direct or indirect contact with the human body meet biocompatibility requirements before being placed on the market. The purpose of this standard is to identify the potential risks of materials and products used to humans and to provide a framework for managing these risks.

All new or existing medical devices placed on the market within the European Union must have an up-to-date Clinical Evaluation Report as part of the Technical Dossier. Conceptual confusion continues in the industry regarding the basic requirements and best practices regarding the creation and updating of these reports.

To actively and systematically collect, record and analyze relevant data on the quality, performance and safety of the medical device throughout its life cycle after it is placed on the market, and to determine, implement and monitor corrective and preventive actions; It has become even more important with the implementation of the new Medical Device Directive (EU) 2017/745.

It is necessary to implement an effective quality management system for medical devices that are safe, high quality and have appropriate performance. ISO 13485:2016 has a process-oriented structure and requires a company's process-oriented perspective during the implementation of a quality management system.

As is known, as of 26 May 2021, the (EU) 2017/745 Medical Device Regulation, which came into force on 26 May 2017, is being implemented instead of the 93/42/EEC Medical Device Directive and the 90/385/EEC Active Implantable Medical Device Directive. The new regulation imposes more obligations on all stakeholders in the medical device sector, including manufacturers, importers, authorized representatives and notified bodies, and contains more stringent requirements.

For all new or existing medical devices placed on the market within the borders of the European Union, regardless of risk class, manufacturers are required to prepare Technical Documentation to show that they meet the General Safety and Performance Requirements of Annex I of the (EU) 2017/745 Medical Device Regulation.

With the development of technology, the number of medical device software has increased. It has become important to be able to appropriately and adequately address the verification, documentation, compliance and presentation requirements specific to software-controlled devices in accordance with the legislation and applicable standards. With MDR, a number of important requirements have been introduced in software processes.