Standard Adoption Workshops (SS 620:2016 and ISO 13485:2016) at Singapore Manufacturing Federation

Ms Tan Su Min, Director of Client Success at Stendard, speaking at the “Standards Adoption Workshop on SS ISO 13485 : 2016 - Medical Devices QMS - Requirements for regulatory purposes”,  6 March 2019

Ms Tan Su Min, Director of Client Success at Stendard, speaking at the “Standards Adoption Workshop on SS ISO 13485 : 2016 - Medical Devices QMS - Requirements for regulatory purposes”, 6 March 2019

Workshops at SMF to encourage standards adoption

Stendard collaborated with Singapore Manufacturing Federation (SMF) on two of their recent workshops for the medical device industry. The workshops covered the importance of standards adoption, with particular reference to the ISO 13485:2016 and the SS 620:2016 standards. Participants included Singaporean companies involved in the medical device industry (manufacturers, importers, exporters, distributors and wholesalers).

On 25 February 2019, the Standards Adoption Workshop “SS 620:2016 Good Distribution Practice for Medical Devices - Requirements”, focused on familiarising distributors and importers of Medical Devices with the new SS 620:2016 requirements. Guest speakers from the GDPMDS Working Group and Health Sciences Authority (HSA), shared on differences between the SS 620:2016 and HSA GDPMDS TS-01, R2.1.

The second workshop with SMF on 6 March 2019, focused on “SS ISO 13485:2016 Medical Device -Quality Management System Requirements for regulatory purposes”. This workshop aimed to discuss the basic concepts of ISO 13485:2016 and provide an insight to the use of ISO 13485 as the standard for a quality management system implemented by medical device companies.

At both sessions, we shared how our Stendard Solution™ can be leveraged on to successfully transition and achieve compliance with the SS 620:2016 and ISO 13485:2016 standards.