Incident Assessment Form
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Use this Incident Assessment Form template to systematically evaluate whether a device-related event qualifies as a serious and reportable incident under medical device vigilance requirements. This form is essential for documenting the assessment, supporting compliance with EU MDR Article 87 and ISO 13485:2016, and should be completed whenever an adverse event or potential safety issue involving a medical device occurs. Completing this form ensures proper investigation, recordkeeping, and reporting to competent authorities when required, helping you maintain regulatory compliance and patient safety.