Full US FDA Mastery
for Medical Devices
A complete, hands-on training program designed to make you submission-ready, not just certified. Learn how the FDA actually evaluates, not just textbook theory.
Who is this course for?
QA/RA Professionals
Medical Device Startups
Manufacturers & Consultants
Career Switchers into MedTech
"Submission Ready Mindset"
We teach you what to prepare, why it's required, and how to defend it during FDA review. This is about real-world application.
- Practical example-driven learning
- Confidence to work on real 510(k) projects
- Verifiable Certificate of Achievement
Career Support Included
- LinkedIn Profile Optimization for RA
- JD-to-Resume Mapping
- Salary Strategy & Growth Roadmap
- Job Change Planning (Global & India)
6 In-Depth Modules
Mastering the end-to-end US FDA landscape
FDA Overview
Fundamental overview of US FDA regulations specifically tailored for medical devices.
Steps to Market
- • Know Your Product
- • Confirm Device Status
- • Regulatory Pathway Determination
- • Practical Example
Registration & Listing
- • Requirements & Exemptions
- • Establishment Registration
- • DFUF User Fees
- • FURLS Navigation
510(k) Submissions
- • Types of 510(k) Submissions
- • Document Requirements
- • Review Timelines
- • Practical eSTAR approach
PMA & De Novo
- • Clinical Data Requirements
- • Risk-based Evaluations
- • MDUFA & SBD Program
- • Successful Application Best Practices
Tools & Databases
- • 21 CFR Exploration
- • TPLC & 510(k) Database
- • Important Guidance Links
- • Practical Search Exercises
Important Dates & Access
Onboarding Session
17 May 2026
Live Doubt Session 1
31 May(Sunday)
Live Doubt Session 2
21 June 2026
Included Access
- 3 Months Full Recording Access
- Exclusive Course Materials & Templates
- Practical Assignments & Assessments
- Direct Support & Communication Process
Invest in Your Career
Only 50 seats available. Registration closes on 12 May 2026.
Course Fee
₹9,999/-
Option 1: Scan & Pay (UPI)
UPI ID: rajkumarmishra1616-1@oksbi
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Option 2: Bank Transfer
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Step 2: Complete your registration after payment
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Before you enroll, take a minute to understand what this course offers.
This introduction walks you through the structure, approach, and real-world value you’ll gain.
Demo Lecture: Finding Your Predicate Device
Learn the exact steps to identify the right predicate device for your 510(k) submission.