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About Us

We are founded with the sole purpose of re-inventing the way we diagnose diseases

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Our Story

Sanwa BioTech was established in December 2012 with the vision of transforming the diagnostic landscape.

Our mission is to save lives by streamlining clinical diagnostic processes. We focus on combating time-critical and life-threatening diseases and outbreaks with our automated, multi-target diagnostic testing platform.

 

At Sanwa BioTech, we believe that impending changes are coming of conventional clinical diagnostics & academic R&D for bio-discoveries. We aim to become a driving force for these changes and to revolutionize healthcare solutions into the future.

 

To accomplish our vision, we have developed an effective personalized Point-Of-Care Testing (POCT) platform with digital healthcare solutions. This provides patients with diagnostic results and suitable treatment at unprecedented speeds. With our cutting-edge POCT platform and BioChip system, we deliver accurate and actionable diagnostic results for faster clinical decisions and better economic outcomes. This rapid response and disposable BioChip can be used in human healthcare, pet health, livestock surveillance, and food safety for disease monitoring, especially at the human-animal interface (HAI) to combat infectious disease outbreaks.

Our core team comprises of members from cross-functional backgrounds in business, biotechnology, advanced micromachining, and microfluidic Lab-On-Chip (LOC) technologies. Fuelled by a strong entrepreneurial passion, the team came together to revolutionize the healthcare industry by developing a ground-breaking POCT platform and advanced BioChip for simplified and versatile testing solutions.

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Leadership
From Zero to One
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ISO 13485 Certified

Sanwa BioTech is an ISO 13485:2016 certified medical device manufacturer.

 

ISO 13485:2016 is an internationally recognized quality management system standard for medical device manufacturers. ISO13485 ensures product reliability, regulatory compliance and quality management throughout the life cycle of medical devices, i.e. from product conception to placing the device onto the market, to obsolescence of the device. ISO13485 compliance is a prerequisite for a large number of jurisdictions to place medical devices on the market.

Since our initial certification in April 2018, the company has been annually audited for compliance and has passed every year.