SOP Vigilance
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Use this SOP Vigilance template to guide the identification, investigation, documentation, and reporting of serious incidents and field safety corrective actions (FSCA) for medical devices, ensuring compliance with EU vigilance reporting requirements. Complete this document whenever a potential or confirmed serious incident, FSCA, or related safety concern arises, to fulfill mandatory timelines for notifying competent authorities and maintaining a robust quality management system. This SOP is essential for timely regulatory reporting, risk mitigation, and maintaining product safety in the post-market phase.