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.

We will be at MEDICA 2017, Hall 7A Booth B09

We are launching a MEDICA promotion from now till 30 November 2017, together with our EU authorised representative partner, MT Promedt Consulting GmbH! This would be very attractive if you are looking for CE Marking and/or ISO 13485 support! Come by our booth to find out more information!

If you are not available at the exhibition and would still like to find out more, just feel free to contact us here

 
 

Fearing the unknowns of ISO 13485 - AEvice Health x Stendard

Fearing the unknowns of ISO 13485 - AEvice Health x Stendard

For those who follows up with news around the international start-up scene, you would definitely have heard about AEvice Health Pte Ltd! They are frequently featured in tech news and recently, they were also part of the Channel NewsAsia TV programme, Season 4 of Start-UP and were recently awarded in the Lee Kuan Yew Global Business Plan Competition. With such widespread publicity, AEvice Health is definitely the start-up to look out for.

Breaking the ISO 13485 barrier towards clinical usage - MagnePath (Australia) x Stendard

Breaking the ISO 13485 barrier towards clinical usage - MagnePath (Australia) x Stendard

MagnePath Pty Ltd is a digital health company, with foundations in medical imaging. By inventing the next generation of body analytics to map the health of the human body, their goal is to put a true picture of your health in the palm of your hand.

We had the opportunity to catch up with the CTO, Dr Paul Clark, for this interview to find out what they think about ISO 13485 and how the usage of Stendard First™ has made this journey better.

Why is the new EU IVD Regulation creating a storm?

Why is the new EU IVD Regulation creating a storm?

Just last week, we have discussed on the publication of the new European Medical Device Regulations (MDR), 2017/745. The Regulations has come into force on 25th May 2017, marking the start of the transition period for companies selling medical devices into Europe.  Similarly, the in-vitro diagnostic devices (IVD) has gone from a Directive to an enforced Regulation – 2017/746.

The new EU Medical Device & in-vitro Diagnostic Regulations - How does it impact your organisation?

The new EU Medical Device & in-vitro Diagnostic Regulations - How does it impact your organisation?

Stendard, together with TÜV Rheinland andMT Promedt Consulting GmbH, is organising the first-ever tripartite workshop! Come and get first-hand updates on the new Medical Device Regulation (MDR) and in-vitro Diagnostic Regulation (IVDR), what are Notified Bodies look out for during the audits and how you can utilise eQMS software to better manage your QMS during this transition period.