Medical devices in the focus of the fight against COVID-19

During the two-day webinar held on 5-6 November 2020, the participants had the opportunity to learn about fulfilling the strict quality requirements in each phase of the life cycle of any medical device, as well as how to implement the QMS processes in a correct way (SRPS EN ISO 13485:2017, Medical devices - Quality management systems - Requirements for regulatory purposes).

Part of the webinar was dedicated to the implementation of the usability engineering on medical devices (SRPS EN 62366-1, Medical devices – Part 1: Application of usability engineering to medical devices, directs the manufacturers to analyze, specify, develop and assess the usability of medical devices regarding safety), that refers to the interface between the medical device and the user.
This webinar was attended by the companies dealing with the development, production and distribution of various medical devices, business entities for research and development, Institute of Virology, Vaccines and Sera „TORLAK“, and several conformity assessment bodies.

The distinguished lecturers who shared their vast knowledge and experience at the webinar were:
• Aleksandar Šišković, consultant for QMS and regulations related to medical devices, and
• Dragan Jović, regulatory expert and medical software consultant.

Taking into account the current epidemiological situation, as well as the increased interest of our users and customers, ISS and „SIGMA SYSTEMS” will continue to organize series of webinars referring to the up-to-date topics that focus on medical devices.