SINGAPORE – January 15, 2018
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.
“Since the launch of our platform late last year, we have already helped more than forty companies from Singapore, Australia, Germany and other countries to prepare their compliance documentation in accordance to the new ISO 13485:2016 version,” said Jason Lim, CEO & Co-founder of Stendard.
ISO/TR 80002-2 is applicable to software that supports the design, testing, manufacturing, complaint handling and many other aspects of medical device quality systems as described in ISO 13485. Released in late 2017, Stendard is one of the first companies in the world to attain the ISO/TR 80002-2 certification by TÜV Rheinland. By complying with this standard, Stendard demonstrates its commitment towards quality and reliable software solutions, especially in the medical device sector.
Getting certified to an internationally recognised standard like ISO/TR 80002-2 indicates Stendard’s readiness for global expansion, and a dedication to commit to a structured plan towards its product, services and day-to-day operation. With this certification, Stendard plans to expand their market to other Asian countries through local partners and consultancy firms. The purpose of this expansion strategy is to allow more companies to be able to tap on the software’s capability to fulfil or transit to the new version of ISO 13485:2016, which is fast approaching its transition deadline.
As part of this plan, Stendard also announces the partnership with MEDITIP Co., Ltd., a consultancy firm based in Seoul, to support South Korean companies with conforming and transiting to the new ISO 13485:2016.
“Despite ISO/TR 80002-2 being a requirement for the medical device sector, our decision to conform to this standard sets a high bar and allows us to expand to other international standards with the assurance of the quality, robustness and reliability of our software,” shared Vincent Lim, COO & Co-founder of Stendard.
Stendard’s vision is to help simplify compliance for businesses. Stendard First™ is Stendard’s first product - a cloud-based software that helps companies generate customised documents to meet international standards, like ISO 13485 (incl. US FDA 21 CFR Part 820). Conventionally, such work is performed manually and is very time-consuming. Stendard is the first to help businesses achieve compliance in a fast, convenient, scalable and affordable manner.
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Butler from Stendard