$247 — Standard Tier

Complaint Handling and MDR Reporting Toolkit: FDA 820.198 + Part 803 Templates

Complaint Handling and MDR Reporting Toolkit: FDA 820.198 + Part 803 Templates - complete templates for medical device compliance.

Get the Toolkit — $247

7-day money-back guarantee • One-time purchase • Instant download

What's Included

Complaint Handling Procedure (FDA 21 CFR 820.198 + ISO 13485)
Complaint Investigation Form
MDR Reportability Decision Checklist (21 CFR Part 803)
MDR Submission Form Template (MedWatch 3500A)
Complaint Trend Analysis Template
Complaint Handling KPI Dashboard Template

Benefits

Fully compliant templates ready for regulatory submissions
Saves 20+ hours vs building from scratch
Audit-ready documentation
Used by 500+ device manufacturers

Is This For You?

This toolkit is designed for teams facing these challenges:

FDA 483 observations for missing procedures
No standardized process across product lines
Auditors citing documentation gaps
Starting from blank pages

Who This Is For

QA/RA managers in medical device companiesCompanies preparing for FDA inspection or ISO 13485 auditRegulatory consultantsStartups building QMS from scratch

Frequently Asked Questions

What format are the documents?

All documents are editable Word/Markdown templates ready for direct QMS use.

Is this FDA and ISO 13485 compliant?

Yes, all templates are aligned with current FDA and ISO 13485:2016 requirements.

Ready to Get Started?

Download immediately after purchase. All templates are editable Word and Excel files.

Get the Toolkit — $247

7-day money-back guarantee