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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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ISO13485 (YY/T0287) 内审员培训服务简介 ISO13485：2016《医疗器械质量管理体系用于法规的要求》标准，是应用于医疗器械专用的独立标准，强调满足医疗器械法规要求，随着历史的发展，ISO组织将此标准进行了修订，升级为ISO13485：2016于2016年7月15日发布。国家食品药品监督管理局已按等同采用的原则转化为行业标准YY/T0287-2016。在欧洲欧洲市场上医疗器械生产厂商被强制要求通过认证机构的CE认证。 Time:2018-6-29 11:39:45 View:2851