//

The Stendard team at TIA Singapore 2017. Photo credit: Stendard.

Singapore’s Stendard, an online service helping medical device manufacturers fulfill international standardization regulations, has just announced an undisclosed sum of pre-seed funding.

Stendard’s cloud-based software allows paying subscribers to generate the documentation they need to comply with industry standards such as the International Organization for Standardization’s ISO 13845, which outlines quality requirements for the design and manufacture of medical devices.

Stendard’s platform simplifies the process by eliminating much of the technical jargon that comes with the traditional paperwork, and by offering guidance and pointers as users fill in and file the relevant forms. The startup claims that its streamlined and automated process takes 10 hours, compared to the possible six months – and tens of thousands of dollars – required to complete the existing paper-based procedure.

Co-founders and brothers Jason and Vincent Lim tell Tech in Asia that most of the money came from individual investors working in venture capital, who stumped up their own cash as the company remains too small to fall under the ambit of typical VC funds.

“[The funders] know a few more established companies and this link allows us to look at larger enterprises and new growth opportunities,” says Vincent, who is also the company’s COO. “And possibly other verticals. It is a chance for us to skill up.”

While the brothers report interest in their solution from other sectors where industry standards and regulation play a critical role – including fintech, and food and beverage – they will for now remain focused on the medical device space.

The pre-seed funding will mainly be invested into honing the product, with a view to signing up significantly more users over the next few months.

That said, the Stendard team is already looking at international expansion, as well as possible value-adds that can be built around its core product.

Events and expansion

Jason, the CEO, says that the startup is already working closely with a few Germany-based players in the standardization space, with an eye on a future rollout in the European Union (EU). These partnerships have already proven invaluable, as the EU recently updated its medical device regulations.

Stendard is also developing workshops and other events to educate medtech companies about industry standards.

“They’ve told us what we need to modify and change in our platform for the EU market,” says Jason. “That will help with getting big companies to see Stendard as a good platform to leverage.” The company is also looking at similar opportunities in Japan, he adds.

Stendard is also developing workshops and other events to educate medtech companies about industry standards and their related compliance obligations. One workshop, to be held in Singapore next month, will outline the EU’s new medical device and in-vitro diagnostics regulations. “It is a good opportunity to educate people about us – not just what we can do as software company, but what we can do in terms of an ecosystem, in terms of training and consultancy,” says Vincent.

While the pre-seed cash will help expand these initiatives, Stendard has plans in place for its next funding injection. “We are aiming to close a seed round in 12 to 18 months,” says Jason. “As a ballpark estimation, we’ll be targeting around US$800,000 to US$1 million. That would give us a good base to work with, and to make some new hirings.”

Stendard launched its service earlier this year, and has signed up around 10 companies as users so far.

This post Singaporean startup gets funding to help medtech meet international standards appeared first on Tech in Asia.

from Startups – Tech in Asia http://ift.tt/2svDlOT