ISO 13485 Documentation

Complete bundle or individual SOPs — audit-ready, instantly downloadable.

✓ 70+ editable documents ✓ 22 QMS processes covered ✓ Instant download ✓ Word & Excel format
Get the Complete Bundle — €299
Browse individual SOPs ↓
ISO 13485 QMS documentation bundle

Complete Bundle

ISO 13485 QMS Documentation Bundle

Everything you need to build a fully compliant ISO 13485 QMS — without starting from scratch.

  • ✓ 70+ editable documents
  • ✓ 22 QMS processes covered
  • ✓ Word & Excel format
  • ✓ Instant download after purchase
  • ✓ Written by ISO 13485 Lead Auditor

€299

Or buy only the SOP you need

Each SOP is instantly downloadable in fully editable Word and Excel format.

SOP PackagePrice
Management Review SOP
Procedure + Meeting Template
€59
Buy
SOP PackagePrice
Risk Management SOP
Procedure + Plan + Report + Risk Analysis + Hazard Analysis + Traceability Matrix
€59
Buy
SOP PackagePrice
Audit Management SOP
Procedure + Annual Plan + Audit Plan + Audit Report
€59
Buy
SOP PackagePrice
Human Resources & Training SOP
Procedure + Templates
€59
Buy
Infrastructure & Work Environment SOP
Procedure + Control of Equipment
€59
Coming Soon
SOP PackagePrice
Computer System Validation SOP
Procedure — ISO 13485 & GAMP 5
€59
Buy
SOP PackagePrice
CAPA SOP
Procedure + CAPA Template + CAPA Database
€59
Buy
Non-Conformity Management SOP
Procedure + Templates
€59
Coming Soon
SOP PackagePrice
Change Control SOP
Procedure + Notified Body Notification Procedure + Template + Database
€59
Buy
SOP PackagePrice
Document Control SOP
Procedure + Approval Template Sheet
€59
Coming Soon
SOP PackagePrice
Complaint Management SOP
Procedure + Template + Complaints DB + Feedback DB + EU Vigilance Procedure + Field Actions Procedure
€59
Buy
SOP PackagePrice
Design & Development SOP
D&D Plan + Inputs + Verification Plan + Transfer Checklist + Design Review + DHF Index + DMR Index + Biological Risk Assessment
€59
Coming Soon
SOP PackagePrice
Supplier & Purchase Management SOP
Supplier Procedure + Initial Evaluation + Monitoring + Purchase Procedure + Purchase Order + Supplier List
€59
Coming Soon
SOP PackagePrice
KPI & Data Analysis SOP
Procedure + KPI List Template + QMS Risk Analysis Template
€59
Coming Soon
SOP PackagePrice
Post-Market Surveillance SOP
PMS Procedure + PMS Plan + PMS Report + PSUR Template
€59
Coming Soon
SOP PackagePrice
Clinical Evaluation SOP
Procedure + Investigator Brochure Template
€59
Coming Soon
UDI Management SOP
Procedure
€59
Coming Soon
Medical Device File SOP
Procedure
€59
Coming Soon
Customer-Related Process SOP
Procedure
€59
Coming Soon
Sterilization Validation SOP
Ionizing Sterilization Procedure
€59
Coming Soon
Manufacturing Operations SOP
Production & Service Provision + Incoming Control
€59
Coming Soon
Usability Management SOP
Procedure + Usability File Template
€59
Coming Soon
Process Validation SOP
Procedure
€59
Coming Soon