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服务@ MedtechBOSS
质量管理体系/技术/临床/质量文件
QUALITY AND TECH ADVISORY
MedtechBOSS provides Technical Files, MDF, ISO 13485, US QSR, GMP, GDP, MDSAP, CE MDR, MDD, IVD, IVDR Setup and Maintenance in Americas, ASEAN, Asia, Middle East and Europe.
MedtechBOSS provides advisory, set-up and maintenance for
Manufacturer:
Technical Documentation (SaMD, Technical File, Medical Device File, Design History File, Clinical Evaluation, PSUR, ISO 20417)
Quality Management System (EN/ISO 13485, US QSR, GMP, CPAKB, MDSAP, CE MDR, CE IVDR)
Distributor:
Quality Management System (GDP, GDPMD, SS620, CDAKB)
Other services:
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Conduct internal audit
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Conduct audit to critical supplier
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Support external certification/surveillance audit
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Conduct gap analysis and closure on QMS
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Conduct gap analysis and closure on Technical documentation
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Provide regulatory strategy report
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Ad Hoc Consultancy on Quality, Risk Management & Regulatory
Our team can setup document electronically or hardcopy. Refer details in our QuikQuality website.
产品注册
牌照持有
额外的RA/QA支持
药物服务
健康安全
