ISS announces new seminar – Application of risk analysis in medical devices

On 1 March, 2024, the Serbian Chamber of Commerce and Industry and the Institute for Standardization of Serbia are organizing a seminar on the topic of “Application of risk analysis for medical devices”.

The safety of a medical device is one of the basic criteria that must be met before placing a medical device on the market. Safety is a necessary condition that directly affects not only the health of users, but can also affect their lives.

Therefore, safety is an aspect that is given the greatest attention in risk management, control of the correct functioning of medical devices, and standards in this area can be of great help. Their requirements define obligations and guidelines for achieving and maintaining a high level of security

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

The seminar is intended for organizations that:

- develop, manufacture, sell and distribute medical devices;

- are suppliers of medical devices;

- perform servicing of medical devices, under license or in their own name;

- provide consulting services during development, production and after-sales activities;

- participate in checks, in the process of certification and assessment of technical documentation of medical devices;

- are associated with software related to a medical device, or the software itself is a medical device

Date, time and venue of the seminar: 1 March, 2024, 10:00 – 14:00, Serbian Chamber of Commerce and Industry, Resavska 15, Meeting hall 1