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EN ISO13485:2016 Certification: A Big Milestone!



StratifiCare is proud to announce that we are officially EN ISO 13485:2016 certified!

This accreditation was delivered by TÜV SÜD PSB after a stringent auditing process, and it presents as a significant milestone towards our founding vision of empowering personalised medicine for tomorrow.


At StratifiCare, we build quality into our culture right from the start, and strive to design quality in vitro diagnostic products for patients worldwide. Our design process (quality management system) adheres to the highest of international standards for the design and development of in vitro diagnostic tests, and is in compliance with regulatory requirements by the US FDA (21 CFR Part 820) and the European Union (IVDD 98/79/EC), which along with EN ISO 13485:2016, are international standards which all medical device MNCs adhere to.


As one of the only few medtech startups in Singapore to be certified, our EN ISO 13485:2016 certification reaffirms our ability to consistently meet customer and regulatory requirements. We are taking solid steps forward in our product development, and we welcome all interested parties to reach out to us!


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