Safety and Regulations

Sanwa BioTech holds itself to high safety and sanitary standards to ensure staff safety and product quality.

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.