Quality system establishment and management services for medical device manufacturers including ISO 13485 compliance, documentation systems, and regulatory audit support.
Manufactured by
Chongqing JoinShare Pharmaceutical Technology Co.,Ltd.
China
Chongqing JoinShare Pharmaceutical Technology is a third-party medical device registration and incubation platform established in 2019. The company operates a 12,000 sqm facility with twelve production lines capable of manufacturing active devices, passive devices, and in-vitro diagnostic reagents. Services include medical device R&D, registration filing, quality management system development, quality testing, standardization verification, and contract manufacturing. The platform has served over 200 enterprises with 200+ product registrations.
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Tegra Medical LLC · United States
Quality management services ensuring ISO 13485 and FDA QSR compliance throughout medical device manufacturing. Integrated into comprehensive contract manufacturing solutions.
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Quality management and assurance services for medical device manufacturers. Supports compliance with international standards and regulatory requirements in medical device production.
Guangzhou MedClear Medical Device Service Co., Ltd. · China
Provides quality and regulatory consultation services for medical devices, including regulatory compliance, quality management systems, and full lifecycle product support. The service includes sterilization validation, sterilization processing, testing, and regulatory consulting to ensure complete compliance throughout the product lifecycle.
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