Sterilization Process Validation — Process Package (ISO 13485)
€69.00Sterilization Process Validation SOP — supplier-provided validation framework per ISO 11135/17665/11137. SOP only (no templates — supplier provides validation docs).
Showing 33–37 of 37 results
-
-
Strategy for Regulatory Compliance — Process Package (ISO 13485)
€69.00Strategy for Regulatory Compliance SOP with PRRC Qualification Record per EU MDR Art. 15(1) — pathway (a) or (b).
-
Supplier Management — Process Package (ISO 13485)
€69.00Supplier Management SOP with Evaluation Form, Approved Supplier List (Excel), and bilateral Quality Agreement.
-
UDI Management — Process Package (ISO 13485)
€69.00UDI Management SOP with UDI Master List (Excel) for EUDAMED + FDA GUDID submission tracking.
-
Usability Engineering — Process Package (ISO 13485)
€69.00Usability Engineering SOP with Use Specification & URRA combined and Usability Engineering File (UEF) Summary. Aligned with IEC 62366-1 + FDA HFE 2016.