National Service Hotline:
One-stop chemical compliance services, providing chemical compliance consulting services
Quality Management System
1. Medical device quality management system origin
Quality management system (Quality Management system, QMS) refers to the quality of command and control of the organization's management system. A QMS is an organization's approach to ensuring that the quality of its products or services meets the expectations and needs of its customers. The main goal of QMS is to ensure the consistency and reliability of the product or service, as well as to maximize the satisfaction of customer expectations and needs.
2. Medical device industry quality management system requirements
The product quality risk of medical device industry is closely related to human life and health, and the product quality supervision needs to be based on the regulations and standards of various countries, so on ISO9001 basis, the ISO13485(GB/T42061) medical device quality management system is developed for the requirements of the special QMS standard.
In order to be more intuitive and more instructive, the National Drug Administration has established a complete set of medical device specifications for the construction and maintenance of the quality management system of medical device manufacturers.
ØGB/T 42061-2022Medical device quality management system for regulatory requirements
ØMedical device production quality management standard on-site inspection guiding principles
ØStandard for quality management of medical device production Guiding principles for on-site inspection of sterile medical devices
ØStandard for quality management of medical device production Guiding principles for on-site inspection of implantable medical devices
ØStandard for quality management of medical device production Guiding principles for on-site inspection of in vitro diagnostic reagents
ØStandard for quality management of medical device production Guiding principles for on-site inspection of customized denture
ØMedical device production quality management standard independent software on-site inspection guidelines
ØGuidelines for the verification of quality management systems for medical device registration
ØMedical equipment management quality management specification
ØGuidelines for on-site inspection of quality management of enterprises specializing in the provision of transport and storage services for medical devices
3. Our Services
National Service Hotline:
Beijing Headquarters: D10, Floor 4, Block A, Borui Building, No.26, Dongsanhuan North Road, Chaoyang District, Beijing, China
Tel: 86-010-6471 0683
Shanghai: Room D308, Zhongyi International Building, Puxing Highway 800, Minhang District, Shanghai
Tel: 86-021-3478 3993
Guangzhou: Room 201, Xinying Technology Park, No. 313 Jinxin Avenue, Panyu District, Guangzhou
Tel:400 660 1329
E-mail：nar@china-reach.net
Copyright: New Anrun (Beijing) Consulting Co., Ltd.
