GRZAN Group Limited (GRZAN) is a service provider focused on providing comprehensive technical services for global regulatory registration, clinical trials, and Inspection & Testing Guidance, etc. for medical devices and in vitro diagnostics companies.
Over the years, we have established a well-developed service network and professional localized teams in many important markets around the world.
Our Core Services
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Regulatory Consulting
(NMPA、RZN、CE-MDR&IVDR、FDA & 510(k)、Southeast Asia (indonesia, Malaysia, Vietnam, Singapore, Thailand, Philippines)、TGA、MHRA & UKCA、MDL& MDEL、India CDSCo、Bangladesh DGDA、Southeast Asia (indonesia, Malaysia, Vietnam, Singapore, Thailand, Philippines)、Central Asia、Middle East (Saudi Arabia,UAE,etc.)、Latin America (Brazil,Mexico,etc.)、Africa、ClS Countries,etc.)
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Clinical Trial Research
(Clinical Trial Research、Study Protocols and Reports、Statistical Analysis of Clinical Data、Clinical Trial Monitoring、Ethics Application and Approvals、Subiect Recruitment and Trial Execution、Usability Studies、Project Management and Oversight)
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Testing support
(Electrical Safety Testing、Environmental Reliability Testing、Packaging Validation Testing、Registration Testing（Domestic & nternationa）、Product Baseline Testing、Cybersecurity Testing、Biocompatibility Testing、Other Commissioned Testing)
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Quality System Consulting
(MDSAP、QSR 820、ISO 13485、GMP、BGMP、GOST Russia GOST、IVDR 2017 746/EC、MDR 2017/1745/EC、China GMP、Korea GMP、Medical Device GMP、Medical Device GDP、Production Site Planning)
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Authorized Representation
(EU Rep、U.S.Agent、UK Rep、CH Rep、RUS Rep、HK Rep、BR holder、License Holder in Southeast Asia)
With a global service network and localized teams, GRZAN delivers one-stop regulatory solutions to help clients enter international markets with speed and compliance.
