ISO 13485

ISO 13485:2016 - Medical Devices Quality Management System Training is Now Online!

ISO 13485:2016 - Medical Devices Quality Management System Training is Now Online!

If you're looking to get the ISO 13485: 2016, we have good news for you! 

Our team at Stendard has come up with an online course to provide this training for you, at your convenience!

With this, you can schedule and enjoy learning at your own pace and space. Get trained from your desk at home or at your office, anytime possible!

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

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

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).

[MEDIA RELEASE] Stendard - MEDITIP partnership: Bringing world’s first bilingual compliance platform for ISO 13485 and KGMP: The Stendard Solution™

[MEDIA RELEASE] Stendard - MEDITIP partnership: Bringing world’s first bilingual compliance platform for ISO 13485 and KGMP: The Stendard Solution™

Meeting Quality Management System (QMS) requirements is clearly a global need, across all borders. Overcoming language barriers, Stendard is excited to announce a further collaboration with MEDITIP Co. Ltd., in Seoul, Republic of Korea, to bring Korean medical device companies the world’s first bilingual compliance platform: Stendard Solution™.

MEDIA RELEASE: Achievement of ISO/TR 80002-2:2017 Certification

MEDIA RELEASE: Achievement of ISO/TR 80002-2:2017 Certification

Stendard today announced the achievement of the ISO/TR 80002-2 certification for Stendard First™, an innovative cloud-based software designed to simplify compliance for businesses. The software helps companies generate customised documents to meet international standards, like ISO 13485 (incl. US FDA 21 CFR Part 820) and many other internationally regulated standards. Conventionally, creation of such documentation is performed manually and is very time-consuming. Launched in September 2017, Stendard strives to help small businesses achieve compliance in a fast, convenient, scalable and affordable manner.