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FDA申请 & ISO 13485:510(k)、De Novo & PMA 的质量管理体系

在美国，医疗器械根据 21 CFR 860 建立的基于风险的分类系统进行监管。根据
7月 16, 2025
# ISO 13485
# MDSAP- 医疗器械单一审核计划
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TISAX® 2025: Why Quality Managers Need to Lead the Cybersecurity Conversation

As cybersecurity expectations rise across the automotive industry, information security is no longer
7月 16, 2025
# TISAX (Информационная безопасность в автомобильной промышленности)
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Green Finance with Teeth: Second-Party Opinions for Credibility and Capital Access

Experts from DQS and PNC Bank told us how assurance and SPOs are reshaping green bonds, loans, and s
7月 15, 2025
# Сертификация устойчивого развития
# Отчетность в области устойчивого развития и показатели ESG
# Комплаенс и правовой анализ
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医疗器械统一标准

什么是统一标准？根据 (EU) No 1025/2012 法规，“统一标准”是指由公认的欧盟
7月 11, 2025
# ISO 13485
# 医药产品的初级包装材料
# CE标识
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Smarter Medicine or Data Dilemma? AI's Role in Healthcare

Artificial intelligence (AI) is rapidly transforming the way healthcare is delivered. From drafting
7月 11, 2025
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Equivalent Certification Accreditations for Public Works in HK

To strengthen quality management in public works projects, the HK Development Bureau (DEVB) requires
7月 10, 2025
# Менеджмент качества ISO 9001
# Système de gestion de la qualité
# Требования к менеджменту качества
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