Certificates

Certifications and Qualifications

We are committed to delivering high-quality products that meet international standards. Our products are certified with various global certifications, including ISO9001, ISO14001, ISO13485 and BSCI RoHS, CE, CB, UL and other relevant safety and quality standards. These certifications ensure that our products meet the strict requirements of the European and North American markets, giving our clients confidence in the safety, reliability, and performance of our products.

We adhere to a strict quality assurance process, ensuring that each product is rigorously tested for durability, performance, and compliance with industry regulations. Our factory is also regularly audited by third-party organizations to maintain compliance with international standards.

ISO 9001 is an international standard that specifies requirements for a quality management system (QMS). Organizations use the standard to demonstrate their ability to consistently provide products and services that meet customer and regulatory requirements

GMP QSR-820 refers to the Good Manufacturing Practice (GMP) Quality System Regulation (QSR) Part 820. This is a medical devices regulation enforced by the U.S. Food and Drug Administration (FDA)

BSCI stands for a global supply chain and company audit called Business Social Compliance Initiative. BSCI provides companies with a systematic approach to improve their working ethicacy.

ISO 14001 is an environmental quality control. The standard is designed to help organizations systematically reduce their environmental impact, improve resource efficiency, and reduce waste.

ISO 13485 is an international standard that specifies requirements for a quality management system (QMS) specific to the medical devices industry.