OUR SERVICES
Consultation services for Quality Systems of medical device enterprises
● Guidance on establishing medical device quality management systems compliant with ISO 13485 (GB/T 42061), China\'s Good Manufacturing Practice (GMP), US 21 CFR Part 820 (QSR/QMSR), CE MDR, MDSAP, and other applicable regulations.
● Medical Device Quality System Preliminary On-site Assessment
● Our professional service team having served over 2,000 enterprises
● Helps enterprises identify and improve their quality management systems
● Provides on-site inspection services(unannounced supervision and inspection) for enterprises.
● Enable enterprises to discover system noncomformity in advance, enhance regulatory compliance and product quality
● Factory setup guidance (including plant location selection/design, cleanroom design, and layout of production line)
● Process validation and verification assistance (including special processes/critical processes, and cleanroom-related systems such as Purified Water/HVAC/compressed air)
● Medical device product design quality (including new product development process/risk management, etc.) improvement coaching
● Contracted second-party audits
● Class II/III medical device production license and Class I production filing certificate application support
● Guidance on establishing a quality management system compliant with the Good Supply Practice (GSP) for medical devices
● Class III medical device distribution license and Class II medical device filing certificate application support
TELEPHONE
（+86）-755-26910212
cjh@szmdqa.org
ADDRESS
Room 3E,3/F,JiuZhou DianQi Building,KejiNan 12 Road,KejiYuan,NanShan District,
Shenzhen,Guangdong,P.R.China 518063
2014-2026 Shenzhen Medical Device Quality Promotion Association. All rights reserved
