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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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工藝驗證流程為保證穩(wěn)定地生產(chǎn)合格產(chǎn)品，投產(chǎn)前對產(chǎn)品生產(chǎn)系統(tǒng)所進行的驗證工作。它的內(nèi)容是：根據(jù)設(shè)計質(zhì)量的要求，利用生產(chǎn)系統(tǒng)影響產(chǎn)品質(zhì)量的規(guī)律性，通過試生產(chǎn)，對設(shè)備、原材料和零配件、工藝和操作規(guī)程以及生產(chǎn)環(huán)境等進行分析，確認(rèn)生產(chǎn)系統(tǒng)所生產(chǎn)的產(chǎn)品能達到質(zhì)量要求，以保證投產(chǎn)后產(chǎn)品能夠穩(wěn)定地符合各項質(zhì)量要求。 Time:2018-6-29 11:36:24 View:3002