$247 — Standard Tier

QMSR Transition Toolkit: FDA Part 820 to ISO 13485 Alignment

Complete QMSR transition toolkit with gap analysis, implementation timeline, and compliance checklists. Align your QMS with FDA's new ISO 13485 requirements before the February 2027 deadline.

Get the Toolkit — $247

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

What's Included

QMSR Gap Analysis Matrix (Part 820 vs ISO 13485)
Implementation Timeline & Project Plan
Management Representative Duties Checklist
Documentation Mapping Workbook
Internal Audit Checklist (QMSR-aligned)
FDA Inspection Readiness Guide

Benefits

Identify every gap between current Part 820 QMS and QMSR requirements
Structured implementation timeline to meet Feb 2027 deadline
Audit-ready documentation from day one
Save months of consulting fees

Is This For You?

This toolkit is designed for teams facing these challenges:

Unclear what changes QMSR requires
No structured plan to meet the deadline
Worried about FDA inspection post-QMSR
Limited internal resources for transition

Who This Is For

Any FDA-regulated medical device companyQA/RA managers planning QMSR transitionConsultants helping clients with QMSR

Frequently Asked Questions

When is the QMSR deadline?

February 2, 2027. All FDA-regulated device manufacturers must comply.

Do I need ISO 13485 certification?

No, but your QMS must align with ISO 13485:2016 requirements.

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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