Mar 06 2019

Standards Adoption Workshop
Biomedical Standards Industry Series 2019
SS ISO 13485 : 2016
Medical devices - Quality management systems - Requirements for regulatory purposes

06 Mar 2019 02:30PM to 06 Mar 2019 05:00PM
Concourse Auditorium

Registration Date


25 Feb 2019 05:30PM to 03 Mar 2019 07:00PM

SMF Member Fee



GS1 Member Fee



Non-Member Fee



Event Details

Event Type



Industry Group


Medical Technology

Contact Person


Long Huai She


The Biomedical Standards Industry Series consists of a series of in-depth briefing sessions/workshops for biomedical-related companies that are interested and ready for standards implementation. These workshops will cover new and existing standards.

Industry experts will share how they have leveraged on standards to address some of their challenges and opportunities in the field of med-tech devices manufacturing and distribution. 

Participants will also obtain insight on how standards can help their organisations gain market access, improve the quality of products, services and raise in-house productivity.

ISO 13485 is widely utilised as a pre-requisite for manufacturing and/or distribution of medical devices in many countries. The basic concepts of ISO 13485:2016 will be discussed at this workshop with the aim to provide an insight into the use of ISO 13485 as the basis for a quality management system implemented by medical device manufacturers.


Singapore has adopted the ISO 13485:2016 as a Singapore Standard (SS). The content of the SS ISO 13485:2016 is identical ISO 13485:2016 and may be used as reference material for ISO 13485:2016 accreditation.

Administrative Details

Programme is tentative and is subject to change at the sole discretion of Singapore Manufacturing Federation. 

Should you require further information or assistance, kindly contact
Ms Cherie Ong at 6826 3039 / Mr She Long Huai at 6826 3102.

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