$197 — Entry Tier

RA Job Aid Library Toolkit: FDA and EU MDR Quick Reference Tools

RA Job Aid Toolkit — FDA submission timelines, 510k completeness checklist, regulatory pathway decision tree, 483 response guide, EU MDR milestone timeline, and regulatory glossary.

Get the Toolkit — $197

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

What's Included

FDA Submission Timeline Reference Card
FDA 510k Submission Completeness Checklist (eSTAR)
Regulatory Pathway Decision Tree (Reference Card)
FDA 483 Response Strategy Quick Reference Guide
EU MDR Key Milestones and Transition Timeline Reference
Medical Device Regulatory Acronym and Term Glossary (200+ entries)

Benefits

FDA timeline card covers all submission types with real-world expectations vs statutory periods
510k completeness checklist covers all eSTAR sections with RTA risk indicators
Pathway decision tree usable in product development kickoff meetings
Glossary covers 200+ FDA, EU MDR, ISO, and IMDRF terms in one reference

Is This For You?

This toolkit is designed for teams facing these challenges:

RA team members unsure of FDA review timelines for different submission types
510k submitted with missing required elements causing Refuse to Accept determination
Regulatory pathway determination inconsistent across product development team
EU MDR transition milestones not tracked causing compliance gaps

Who This Is For

RA associates building foundational regulatory knowledgeRegulatory coordinators supporting multiple simultaneous submissionsRA managers training new team membersProduct development teams needing regulatory pathway guidance

Frequently Asked Questions

Who are these job aids designed for?

RA professionals at all levels who need quick-reference tools for daily regulatory work, from first-time 510k preparers to experienced directors training staff.

Are these current with FDA and EU MDR requirements?

Yes, all content reflects current FDA eSTAR format, recent FDA guidance updates, and current EU MDR transition provisions.

Related Toolkits

510(k) Submission

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Regulatory Cover Letters

$197

FDA Pre-Submission Q-Sub

$347

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