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 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!
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.
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.
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.
As you might have heard, the EU Medical Devices Regulation (MDR) has been enforced recently, possibly impacting every medical device that are already selling in Europe or intending to be sold in Europe. Out of the entire list of new implementations within the EU MDR, we have handpicked 6 of them that are likely to affect most of you.
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.