Department of Electronic and Telecommunication Engineering

ENTC

Guest Lecture on Medical device regulation and Overview to FDA Approach

Design and development of medical devices occupies a significant portion in electronics manufacturing industry. Compared to general consumer electronic devices, medical devices are subjected to stricter regulations to ensure the safety and wellbeing of the users. Among many regulating standards, United States Food and Drug Administration (FDA) standards of medical device regulation are considered as comprehensive guidelines by medical device manufacturers throughout the world.  Therefore, it is a timely need for undergraduates aspiring to enter the medical device manufacturing industry to be aware of this background.

The guest lecture on medical device regulation and overview was successfully held on the 23rd of November 2017 in the premises of the Department of Electronics and Telecommunication Engineering of the University of Moratuwa with the participation of undergraduate students from several universities. The lecture was facilitated by resource personnel from Synergen Technology Labs, a leading Sri Lankan technology firm specializing in IOT and healthcare devices. Ms. Nuwanthika Rajapaksha and Ms.Udari De Alwis, both research engineers at Synergen Technology Labs, conducted the session.

The lecture session provided detailed insight into the subject of medical device regulation. Starting from the formal definition of medical devices, the lecture encompassed a wide range of topics including the need for regulation, premarket and post market requirements, FDA product classification and FDA guidance documents and best practices.

As a globally recognized standardizing benchmark, FDA compliance is one of the highest standards to which a medical device can be standardized. As budding inventors and designs it is of critical importance to pay attention to the quality aspect of device manufacturing at the early stages of product design and development. The lecturers provided clear guidance on the process of successfully obtaining FDA approval for a device that they would design in the future. This is quite beneficial for undergraduates who have the potential to design novel medical devices to also enter the medical device manufacturing industry as entrepreneurs.

The event was organized by the IEEE Engineering and Medicine and Biology Society (IEEE EMBS) Student Branch Chapter of University of Moratuwa. IEEE EMBS is the world’s largest international society of biomedical engineers. The Student Branch Chapter of University of Moratuwa acknowledges the support provided by the academic staff of the Department of Electronics and Telecommunication in making the event a success.

Guest Lec