This startup helps small medtech companies meet international standards

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It’s good to have standards, as anyone with a meticulously filled dating profile will tell you. In the case of companies making products like medical devices, standards are life-saving.

That’s why organizations like the International Organization for Standardization (ISO) and others have created benchmarks for quality control purposes and guidelines for products and services to abide by.

The process takes hours, where traditionally it would take months.

Adhering to those standards is often costly and involves a lot of documentation. On top of that, audits by independent consultants can take months to complete.

This is the problem Stendard wants to solve for small businesses, to whom this process can be difficult and expensive.

The Singapore-based startup specializes in compliance and standardization for small companies that make medtech products. “We plan to digitize and simplify the entire compliance process for small businesses and change how they look at compliance itself – not like a liability but as an asset,” Stendard co-founder and CEO Jason Lim tells Tech in Asia.

Standard issue

The website helps companies generate the documentation they need for the compliance process by answering a series of questions about a company’s internal procedures, staff, and products. Available on a subscription basis, it’s designed to use simplified language rather than complicated jargon so users can feel confident when using the service.

The software then compiles these answers into standard operating procedure (SOP) documents for each of the company’s departments. Additionally, the service includes form-filling features for things like tracking design changes in a product. The site guides the user through every box and explains how it should be filled in and why. It also alerts the user when these forms need to be filed.

When the paperwork is done, an auditor can come in to review everything and make sure the company complies with all relevant requirements. According to Stendard, the whole thing takes about 10 hours. The traditional process, where a consultant works with the company to ensure compliance, takes about six months and costs tens of thousands of dollars, the team says.

Stendard co-founders Vincent (L) and Jason Lim. Photo credit: Stendard.

Service hero

Jason knows the space well, having worked as a consultant himself, auditing medtech companies the traditional way. “In terms of moving forward, this is not really the preferred way. Both consultants and companies are not using their resources in the most optimized manner,” he muses.

Together with his brother Vincent, they co-founded the startup to create a straightforward and simplified solution to the problem. Much like startups like Dragon Law and LawCanvas that simplify certain legal processes for small companies that can’t afford to have a law firm on retainer, Stendard sees itself as a software-based helping hand for compliance and standardization.

A large part of the platform is education.

“A large part of our platform is also education,” co-founder and COO Vincent Lim says. “We believe these clients have to get educated, they have to know about these responsibilities. They cannot depend on a consultant. At the end of the audit the consultant is gone and they need to be able to find the appropriate documents and information on their own. That can be really scary for a small business.”

Because standardization is such a regulated process, Stendard worked with international certification group TÜV Rheinland, which evaluated the product and endorsed it. “They said we met the strictest requirements of their ISO standards,” Jason says.

The startup has just launched its website and plans for the service to go live for a few early adopters in December. “Our early customers have given us quite positive feedback in terms of implementation. It’s helped them take ownership of the process, explain a lot of technical jargon into layman’s terms, and save on costs – the key points we see for clients to use the platform,” Jason says.

The team expects to fully launch the platform in February 2017. It hopes to sign up about 30 clients in the first year, targeting Singapore, Malaysia, and Australia.

This post This startup helps small medtech companies meet international standards appeared first on Tech in Asia.

from Tech in Asia https://www.techinasia.com/stendard-profile
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