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.
Showing all 2 results
-
-
Post-Market Surveillance — Process Package (ISO 13485)
€69.00Post-Market Surveillance SOP with PMS Plan and PMS Report (Class I) templates. Aligned with EU MDR Art. 84-86 + Annex III + MDCG 2022-21.
