法规

生命科学、生物技术、制药和医疗device manufacturers are facing regulatory requirements that affect the compliance of their vision and labeling systems. These include FDA 21 CFR Part 11, for digital records submitted electronically for regulated FDA filings, and Unique Device Identifier (UDI) requirements for device labels and packages. Similar versions of these regulations apply in the US and the EU. Cognex vision systems support 21 CFR Part 11 compliance and the integrated label management across supply chains required by UDI.