Medical Devices – Insights to Regulatory Affairs and Quality Assurance
Dear IEEE Members,
IEEE Singapore Engineering in Medicine and Biology Society (IEEE SG EMBS) and IEEE Young Professionals Singapore (IEEE SG YP) would like to invite you to join us in our upcoming seminar on 'Medical Devices – Insights to Regulatory Affairs and Quality Assurance'.
Currently, medical devices are highly regulated in many countries around the world, and increasingly regulated by developing countries too. Without the necessary quality management systems certification and product regulatory approvals by the local health authorities, companies cannot sell their medical devices. The certification and approval timelines vary widely across countries and medical device quality and regulatory knowledge are necessary to optimise the required timelines.
This seminar is a great opportunity for you to:
- Understand the Global and Singapore medical device regulations
- Be familiar with the medical device certification requirements for international and local quality management systems, such as ISO-13485:2016, SS 620:2016, and MDA/RR No 1: Nov 2015 First Revision
- Face-to-face Q&A opportunity with industry professionals in Medical Devices RA & QA
Date: 13 Oct 2018 (Sat)
Time: 10 am to 12pm
Venue: Aspiration Theatre @ Biopolis, Level 2M, Matrix Building, 30 Biopolis Street, Singapore 138671
Tickets
Public: S$10
SMF MTIG Member: S$5
Members of BES / IEEE / IES: Free
How to register?
Visit this link at https://www.eventbrite.com/e/medical-devices-insights-to-regulatory-affairs-and-quality-assurance-seminar-tickets-50018828663
Tickets are limited, on a first-come-first-serve basis. Please register early.
Event is co-organized by:
1) Biomedical Engineering Society (Singapore)
2) IEEE Singapore Young Professionals
3) IEEE Singapore Engineering in Medicine and Biology Society
4) IES Biomedical Engineering Technical Committee
5) Singapore Manufacturing Federation – Medical Technology Industry Group
For enquiries, please contact Mr. Kenneth Cheong at kenneth.cheong@ieee.org
Thank you and see you there!
