Complaint Management — Process Package (ISO 13485)
€69.00Complaint Management SOP with Complaint File template that INTEGRATES the 4-question Reportability Assessment per Art. 87.
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EU Vigilance Reporting — Process Package (ISO 13485)
€69.00EU Vigilance Reporting SOP with PSUR template (per MDCG 2022-21). Covers Art. 87-92 reporting timelines and EUDAMED submission.
