We have always been providing services to enterprises based on the core philosophy of professionalism, rigor and pragmatism.
What Can We Do?
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
Consultation services for medical devices registration in China (NMPA)
● Domestic Medical Device Registration Guidance
● Overseas Medical Device Registration Agency/Guidance Services
● Medical Device Classification Determination Guidance
● Innovative Medical Device Application and Priority Review Application Assistance
● Medical Device Testing Guidance(Type Testing / Submission and Follow-up Inspection)
● Simulated Quality System Inspection for Medical Device Registration
Consultation services for medical devices registration in Overseas
● Strategic planning guidance for overseas medical device registration
● Medical Device registration in EU (CE)/ EU Authorized Representative Liaison
● Medical Device Registration in US FDA (510K)
● Medical Device registration in other territories (e.g., Canada, Australia, Japan, Hong Kong, Taiwan, Macao and Southeast Asia......)
Resource alignment across the medical device industry chain
● Connect R&D resources (universities, research institutions, clinical needs) to support innovative medical device R&D ● Liaise with quality management system certification bodies (ISO 13485, ISO 9001, CE, etc.)
● Provide intellectual property services to protect the rights and interests of medical device R&D achievements
● Collaborate with CDMO/industrial design platforms to offer end-to-end services for medical device contract R&D and manufacturing
● Coordinate factory and equipment resources to meet the facility and equipment needs for medical device R&D and production
● Partner with sterilization and packaging logistics services to provide compliant and effective medical device sterilization and packaging solutions
● Leverage clinical resources such as tertiary hospitals to conduct clinical research and scientific collaboration for medical devices
● Engage suitable clinical CROs to facilitate efficient medical device clinical trials
● Connect with medical device testing/usability study institutions and animal laboratories that meet enterprise requirements to ensure medical device quality
Regulatory training/Talent Cultivation
● Medical Device Quality Management System Internal Auditor Training (ISO 13485 (GB/T 42061), China GMP, US 21 CFR Part 820 (QSR/QMSR), EU MDR, MDSAP)
● Medical Device Management Representative Training
● Medical Device Risk Management Training (ISO 14971 (GB/T 42062))
● Biological Evaluation of Medical Devices Training (ISO 10993 (GB/T 16886))
● Medical Electrical Equipment - General Requirements for Basic Safty and Essential Performance (IEC 60601-1 (GB 9706.1)) Training
● Medical Device Usability Engineering Training
● Medical Device Clinical and Animal Trial Full-Process Compliance Training
● Medical Device Design Development and Quality Assurance Training
● Medical Device Professional Technical Knowledge Training (Sterilization Processes/Cleanroom Environment/Process Water Systems, etc.)
● Medical Device Specialized Testing Technology Inspector Training
● Customized In-house Training for Medical Device Enterprises
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
