As an authoritative certification body accredited by IAS (International Accreditation Service), we focus on providing ISO 13485 quality management system certification services for medical device enterprises, helping them meet global medical device regulatory requirements.

We strictly follow the ISO 13485 standard and various national medical device regulations (such as EU MDR/IVDR, US FDA QSR), and help enterprises establish a sound quality management system through professional audits to ensure product safety and effectiveness. The service scope covers the medical device research and development, production, distribution, and after-sales service industry chain.

Through our certification, enterprises will effectively improve their quality management level, accelerate global market access for products, and enhance customer trust. We provide initial certification, surveillance audit, and re-certification services, fully supported by an audit team with experience in the medical device industry.

Choose us to safeguard the your medical devices quality system! Welcome to ask details and cooperate!