Certification Mark

ISO 13485 standard is a quality management system standard applicable to the regulatory environment of medical devices. Its full name is Medical Devices Quality Management System - Requirements for Regulatory Purposes. The related concepts based on PDCA in ISO 9001 standard are adopted. Compared with the ISO 9001, ISO 13485 is applicable to all types of organizations and is more professional, and focuses on the organizations in related industries such as the design and development, production, storage and circulation, installation, service, outage and disposal.

ISO 13485 standard can help organizations strengthen the management of medical devices and the quality control; ensure the personal safety of patients and provide users with the products of stable quality; meet the requirements of users and make greater contributions to our medical device business .

1st class

Surgical instruments (knives, scissors, forceps, forceps, hooks), gauze bandages, surgical gowns, surgical caps, examination gloves, band-aids, drainage bags, etc.

2nd class

Medical masks, sphygmomanometers, thermometers, medical suture needles, condoms, hearing aids, electrocardiographs, EEG machines, acupuncture needles, microscopes, etc.

3rd class

Implantable cardiac pacemakers, contact lenses, implant equipment, vascular stents, comprehensive anesthesia machines, dental implant materials, intravascular catheters, medical absorbable sutures, intraocular lenses, hemodialysis devices, etc.

GB/T 42061 & ISO 13485

After the medical devices quality management system certification：

Help meet the requirements of domestic and international medical device regulations and facilitate the launch of products to the market;

Strengthen quality management, improve product quality and increase market share;

Eliminate international trade barriers;

Enhance brand image and popularity, and strengthen market competitiveness

The charging standards are detailed in the《管理体系认证公开文件》

Provide the integrated and one-stop system certification

— Integrated multi-system review and product factory inspection, and one-stop service, improving the efficiency

— "Product certification + system certification + export certification" one-stop certification service

Advantages of flexible price

— Reasonable overall price

— Many combined packages to save the costs

Diversified value-added services

— The service capabilities such as testing, system certification, management system standard training, second-party review and product certification are integrated to provide customers with "one-stop" on-site comprehensive training to effectively improve the management effectiveness

— Provide the special training value-added services such as the senior internal auditors of management system, statistical technology, enterprise standard system, enterprise process reengineering, quality management improvement, etc.