Meet our Stendard
Stendard is a cloud based software that simplifies the process for medical device companies to fulfil international regulations, such as ISO 13485 and US FDA 21 CFR, before products are approved for commercialisation.
Conventionally, such work is performed manually and is very time-consuming. Stendard is the first to help small businesses achieve compliance in a fast, convenient, scalable and affordable manner.
Story behind Stendard
The idea of Stendard was born out of frustration. With a wealth of experience in medical technology consultancy, Stendard’s CEO & Co-founder Jason Lim started a consultancy firm in early-2014 specialising in the establishment of Quality Management System (QMS) for small businesses in the Medical Device industry – living and breathing the ISO 13485 and US FDA QSR regulations.
What started off as an interest soon turned into frustration, due to a lack of realistic software support for such time-consuming and specialised task. There were no known software affordable enough to implement, easy enough to use and fast enough to suit the client’s timeline. Clients were expected to wait for months and be billed with high five-digits consultancy fees. These were taking a toll on both our consultants and client, especially the startups and small businesses.
With that, the idea of Stendard was born. Stendard is designed to be lightning fast in the development of QMS structure, providing your team with the helping hand you need to guide you through the journey without the exorbitant price tags. Recognising the importance of having a compliance consultant, we have designed this tool to allow our consultancy partners to advise your team at a higher level too.
Now, you can take a breather and focus on creating great healthcare products for all of us.