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制药和医疗

监管规定

支持监管合规的机器视觉和读码系统

生命科学、生物技术、制药和医疗器械制造商都面临着影响其视觉和标签系统合规性的监管要求。这些要求包括 FDA 21 CFR Part 11(针对以电子方式提交的管控 FDA 备案数字记录),以及针对设备标签和包装的唯一设备标识符 (UDI) 要求。美国和欧盟都有这些法规的类似版本。康耐视视觉系统支持 21 CFR Part 11 合规性和 UDI 要求的跨供应链整合标签管理。

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规定概述磁贴

Regulations Application Segments

21 CFR Part 11 规定

21 CFR Part 11 Regulation

A closer look at how vision systems help ensure 21 CFR Part 11 compliance related to accessibility, audit trails, and validation.

UDI-MDR 规定

UDI/MDR Regulation

Explanation of how machine vision systems help identify and track individual medical devices to remain in compliance with governing bodies.

21 CFR Part 11 规定

21 CFR Part 11 Regulation

A closer look at how vision systems help ensure 21 CFR Part 11 compliance related to accessibility, audit trails, and validation.

UDI-MDR 规定

UDI/MDR Regulation

Explanation of how machine vision systems help identify and track individual medical devices to remain in compliance with governing bodies.

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