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Registration Service of Medical Devices: CRC services Medical Device Business License Medical Device Registration Contract Research Organization ISO 13485 Quality System Certification GMP CE Certification Service FDA Registration (Filing) Software Integrity Verification Service Production process validation service ISO 15378 Medical Package System Certification ISO 13485 Internal Auditors Training Regulatory Services For Medical Devices
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Medical Software Development: Software of Good Supply Practice(GSP) Production System Development Customized software development

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ISO15378医疗包材体系认证 ISO 15378标准规定了医药产品初级包装材料（以下简称“药包材”）生产行业应用质量管理体系ISO 9001:2015的特殊要求。它参照良好生产管理规范（GMP）要求，可用于展示组织具备能力提供能持续满足顾客和法规要求的药包材，并符合国际最佳惯例。ISO15378 是主要的医药包装材料标准，由制药业的利益相关方制定，向医药产品包装材料的供应商提供质量管理体系 (QMS)。 Time:2018-6-29 11:37:28 View:1654