3BY manufacturing facility has been constructed to meet strict international quality standards and regulatory requirements. 
 
Our products are manufactured to meet the highest quality control requirements, carry ISO certificates (ISO13485:2003 and ISO 9001-2008) and are approved by the FDA, as well as other regulatory agencies.
 
3BY's proven quality control system, assures that our clients meet all quality regulations required to ensure the overall quality and safety of their products. We constantly work with our customers to implement and maintain compliant quality systems.
 
Quality is the corner stone of 3BY and it is monitored and maintained by a system that encourages continual improvement.

Certifications & auditing