Additional Capabilities > Windchill Quality Management Solutions > Windchill Regulatory Submissions > Managing Regulatory Submissions > Categories of Regulatory Submissions
Categories of Regulatory Submissions
The following categories are available for a revisable regulatory submission:
• Adverse Event Regulatory Submission (AER)— Submission for a product failure that either put someone at risk or resulted in their death. For information on managing an AER, see Managing Adverse Event Report Regulatory Submissions.
• Establishment Registration Submission (ER)—Submission to register the manufacturing location.
• Regulatory Product Submission (RPS)—Submission to indicate that the product is safe to use.
• Unique Device Identifier Submission (UDI)—Submission to identify a product by a global unique name.
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