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 c...
Manufactured by
Guangzhou MedClear Medical Device Service Co., Ltd.
China
Guangzhou MedClear Medical Device Service Co., Ltd., established in 2017, provides technical services for medical device manufacturers including ethylene oxide sterilization services, regulatory and quality consulting, and laboratory testing. Certified with ISO13485, ISO11135, CNAS, CMA, and registered with US FDA and Japan PMDA.
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Sotas Limited · United Kingdom
Regulatory and quality management consulting services for medical device and IVD manufacturers. Provides expertise in UK, EU, and US regulatory compliance, device registration, management systems, post-market surveillance, and in-country representation throughout the product lifecycle.
CMG MEDDEV SL · Spain
Regulatory, clinical, and quality consulting services for medical devices, in vitro diagnostics, and software-as-a-medical-device (SaMD). Supports CE marking and FDA approval pathways, quality system implementation (ISO 15189, ISO 17025), and compliance with MDR 2017/745, IVDR 2017/746, and 21 CFR standards. Services include regulatory strategy design, requirement analysis, and market authorization across the product lifecycle.
HARBIOS GROUP · China
Comprehensive regulatory and lifecycle management services for medical devices and pharmaceuticals, including compliance consulting, quality assurance, and global regulatory pathway guidance. Supports manufacturers and research institutions from development through market approval and post-market surveillance.
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