510(k) Training – Book, Webinars & Live Workshops

This page lists the 510(k) training that is available through Medical Device Academy, including a new book, 24 webinars and three live workshops.

Live 510(k) Training

Medical Device Academy is teaching three live 510(k) workshops this spring. If you attend one of the live workshops you will create your own personalized project plan for your next 510k submission. If you are interested in registering for a one-day, live 510(k) workshop, click on the city near you. The cost is $774.

  • San Diego, CA – March 7
  • San Francisco, CA – March 8
  • Chicago, IL – April 18

If you cannot travel to one of the live 510(k) workshops, you can also download on-line 510(k) Bookwebinars from Medical Device Academy. The following 24 webinars are already recorded an available for immediate download from our 510k course dropbox folder (individual pricing shown below). You can also purchase all 24 webinars as an on-line 510(k) course series. There is also a book available for 510(k) submissions: “How to prepare your 510(k) in 100 days.” The book will ship on February 6, 2017.

  1. Vol 15 – Biocompatibility – $79
  2. Vol 5 – 510(k) Summary – $79
  3. Vol 19 & 20 – Animal & Clinical Studies – $79
  4. Vol 10 – Executive Summary & RTA Checklist – $79
  5. Redacted FOIA 510k Webinar – $79
  6. FDA Declaration of Conformity (Form 3654) Webinar – $49
  7. Sterilization Shelf Life Webinar – $49
  8. How to Complete a 510k Cover Letter Webinar – $29
  9. Labeling & UDI 510k Requirements Webinar – $49
  10. Device Description Webinar – $29
  11. De Novo Application –  $49
  12. Small Business Qualification Fee for 510k Submission – $29
  13. 510k Hardware & Software Documentation Webinar –  $129
  14. 510k Project Management Lessons Learned Webinar –  $129
  15. How to Combine a 510k Submission with CE Marking and Reduce Your Workload by 35% –  $129
  16. FDA Pre-Sub Meetings –  $129
  17. 510k Submissions: Predicate Device Selection – $129
  18. 510k Submissions: Substantial Equivalence – $129
  19. 510k Submission Section 4: Indications for Use – $129
  20. 510k Project Management Webinar – $129
  21. How to complete Section 6, 7 and 8 of a 510(k) Submission – Free if you submit a question
  22. FDA eCopy Print & Ship Webinar – Free if you submit a question
  23. 510k FAQs Webinar – Free if you submit a question
  24. 510k Software Documentation Webinar – Free Download

FDA eCopy Checklist

Fda_ecopy_checklist_161103

Subscribe to download our checklist.

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