All organizations that deal with medical devices at some stage of their life cycle are obliged to follow and comply with the requirements of applicable standards and regulations for medical devices.
The Institute for Standardization of Serbia, in cooperation with local experts in this field, organized a series of trainings during the previous years, where the professional public had the opportunity to learn more about the requirements of the regulations and standards for medical devices. At the end of last year, a new document SRPS EN ISO 14971:2020/A11 was published, which provides a link between the requirements of the SRPS EN ISO 14971:2020 standard and the European Regulation on Medical Devices 2017/745/EU, i.e. it provides a tabular presentation (Annexes ZA and ZB) compliance of the requirements of the standard with the essential requirements of the Regulation on medical devices 2017/745/EU. Lecturers Aleksandar Šišković and Dragan Jović, experts in quality systems, regulations, standards and software for medical devices, will talk about the practical application of the requirements of the SRPS EN ISO 14971 standard at the webinar.
The webinar will describe the process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices. This process aims to help manufacturers of medical devices to identify the hazards associated with the medical device, to assess and value the associated risks, to control them, and to monitor the effectiveness of those controls. The requirements of the standard apply to all stages of the life cycle of a medical device. The process described in SRPS EN ISO 14971:2020 and SRPS EN ISO 14971:2020/A11:2022 applies to risks associated with a medical device, such as risks related to biocompatibility, data and system security, electrical energy, moving parts, radiation and usability.
The webinar will be held on 12 May, from 10:00 till 13:15.