Medical Device Safety through Risk Analysis Application

The Chamber of Commerce and Industry of Serbia, in cooperation with the Institute for Standardization of Serbia, organized a seminar on 1 March, 2024, for manufacturers and authorized representatives of medical device manufacturers on the topic of risk analysis application in medical devices.

The lecturers were professors Jelena Đuriš, Anđelija Malenović, and Ana Protić from the Faculty of Pharmacy, University of Belgrade, from the Department of Drug Analysis and the Department of Pharmaceutical Technology and Cosmetology, and associates of the Institute for Standardization of Serbia Aleksandar Šišković and Dragan Jović, with the participation of 160 listeners.

The requirements of the standards SRPS EN ISO 13485, Medical devices - Quality management systems - Requirements for regulatory purposes, SRPS EN ISO 14971, Medical devices - Application of risk management to medical devices, SRPS CEN ISO/TR 24971, Medical devices - Guidance on the application of ISO 14971 (in preparation), were specifically presented, as well as the standards referring to the risk in general, that are necessary as the basis for considering risk in various fields (e.g. SRPS ISO 9001, Quality management systems – Requirements, SRPS ISO 31000, Risk management — Guidelines, SRPS EN IEC 31010, Risk management - Risk assessment techniques).

The requirements of specific standards in this area were also presented, such as: SRPS EN IEC 60812, Failure modes and effects analysis (FMEA and FMECA), SRPS EN IEC 61025, Fault tree analysis (FTA) (in preparation), SRPS EN IEC 80001-1, Application of risk management for IT-networks incorporating medical devices - Part 1: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software, etc.

Medical device safety is the basic criterion that must be met before a medical device can be placed on the market. It directly affects not only the health, but also the life of the user, and the standards in this area are necessary instructions that define the obligations and guidelines for achieving and maintaining a high level of safety.

All organizations dealing with medical devices in any phase of the life cycle (design and development, production, storage and distribution, installation or servicing of medical devices, as well as design and development or provision of related activities) are obliged to follow and comply with the requirements of applicable standards and regulations for medical devices.

The participants of the seminar were organizations that develop, produce, sell and distribute medical devices, supply medical devices, service them (under license or on their own behalf), provide consulting services during development, production and post-sales activities, participate in inspections, in the certification process and assessment of technical documentation of medical devices.