• Services
    • Regulatory Strategy
    • Regulatory Submissions
    • Quality Systems Compliance
    • Audits
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Regulatory + Quality Assurance | Michelle Lott | lean RAQA

  • Services
    • Regulatory Strategy
    • Regulatory Submissions
    • Quality Systems Compliance
    • Audits
    • Due Diligence
    • Technical Support
  • Industries
    • Medical Devices
    • Biologics
    • Drugs
  • Videos
  • About
  • FREE

Oh, good choice!

I’m glad you found your way to this page.

This 13-page Regulatory Pathways Assessment guide is probably the most helpful tool I ever created.

Hundreds of downloads later, I confidently assert the guide will help you work through project feasibility and requirements.

And I promise I won’t spam you. Spam is a waste of everyone’s time.

So go ahead. Indulge. It’s free. No commitments. Nada.



Table of Contents
1. PURPOSE
2. DESCRIPTION OF THE DEVICE
3. FDA DEVICE CLASSIFICATION
3.1. Possible FDA product codes
3.2. Differences between available classifications and [your device name]
3.3. Possible predicate devices
4. TOOL TO DETERMINE RISK/BENEFIT PROFILE
5. REGISTRATION, LISTING AND QMS REQUIREMENTS PRIOR TO COMMERCIALIZATION
6. SUBMISSION OPTIONS
6.1. De Novo
6.2. 513(g) Request for Information
6.3. Pre-Sub Meeting
7. APPLICABLE STANDARDS AND TEST METHODS
8. APPLICABLE FDA GUIDANCE DOCUMENTS
9. CONCLUSIONS AND RECOMMENDATIONS

APPENDIX A – 21 CFR 820 ROLES & RESPONSIBILITIES

It’s free. Download it now.



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Michelle Lott helps clients recognize regulatory and quality issues aren't a "burden" – they are strategic advantages when used properly. Her expert team will also strip away any redundant or misdirected activities so you can focus on what really matters:
Winning in the marketplace!

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