$197 — Entry Tier

Dual Compliance Kit: FDA + EU MDR Harmonized Documentation

Harmonized procedures that satisfy both FDA and EU MDR requirements. Single documentation system for US and European market access.

Get the Toolkit — $197

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

What's Included

Harmonized QMS Gap Analysis (FDA vs EU MDR)
Technical Documentation Template (EU MDR Annex II)
Declaration of Conformity Template
EU Authorized Representative Agreement Template
Post-Market Surveillance Plan (Harmonized)
Labeling Compliance Checklist (FDA + EU MDR)

Benefits

Single documentation system for both markets
Avoid duplicate work maintaining two QMS
Clear mapping between FDA and EU MDR requirements
Accelerate EU market entry

Is This For You?

This toolkit is designed for teams facing these challenges:

Managing separate documentation for FDA and EU
Confused about EU MDR technical file requirements
Entering European market for first time
Notified Body audit preparation

Who This Is For

US companies expanding to EuropeEU companies entering US marketCompanies maintaining dual regulatory filings

Frequently Asked Questions

Does this include the full Technical File?

It includes the structure and key templates. Clinical evaluation and risk management are separate toolkits.

Do I still need a Notified Body?

Yes, for Class IIa and above devices. This toolkit helps you prepare documentation for NB review.

Related Toolkits

Post-Market Surveillance

$247

Clinical Evaluation (CER)

$297

QMSR Transition

$247

Ready to Get Started?

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

Get the Toolkit — $197

7-day money-back guarantee