510k Course Series - 24 Webinars, the 510k Book and Our Templates

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This is a webinar 510k course series consisting of 24 webinars, a hard copy book and electronic templates for your next 510k submission.510k Course Banner 1024x343 510k Course Series   24 Webinars, the 510k Book and Our Templates

Buy the 510k course series for $1,200

510k Course thumbnail 150x150 510k Course Series   24 Webinars, the 510k Book and Our Templates
510k Course Series

This is a webinar 510k course series consisting of 24 webinars, a hard copy book and electronic templates for your next 510k submission. I recently added a full set of templates for a 510(k) pre-submission request as well.

Price: $1,200.00

The following webinars are already recorded an available for immediate download from our 510k course dropbox folder (individual pricing shown below):

  1. How to prepare your 510k in 100 days – $79 pre-order book (shipping February 2017)
  2. Vol 15 – Biocompatibility – $79
  3. Vol 5 – 510(k) Summary – $79
  4. Vol 19 & 20 – Animal & Clinical Studies – $79
  5. Vol 10 – Executive Summary & RTA Checklist – $79
  6. Redacted FOIA 510k Webinar – $79
  7. FDA Declaration of Conformity (Form 3654) Webinar – $49
  8. Sterilization Shelf Life Webinar – $49
  9. How to Complete a 510k Cover Letter Webinar – $29
  10. Labeling & UDI 510k Requirements Webinar – $49
  11. Device Description Webinar – $29
  12. De Novo Application –  $49
  13. Small Business Qualification Fee for 510k Submission – $29
  14. 510k Hardware & Software Documentation Webinar –  $129
  15. 510k Project Management Lessons Learned Webinar –  $129
  16. How to Combine a 510k Submission with CE Marking and Reduce Your Workload by 35% –  $129
  17. FDA Pre-Sub Meetings –  $129
  18. 510k Submissions: Predicate Device Selection – $129
  19. 510k Submissions: Substantial Equivalence – $129
  20. 510k Submission Section 4: Indications for Use – $129
  21. 510k Project Management Webinar – $129
  22. How to complete Section 6, 7 and 8 of a 510(k) Submission – Free if you submit a question
  23. FDA eCopy Print & Ship Webinar – Free if you submit a question
  24. 510k FAQs Webinar – Free if you submit a question
  25. 510k Software Documentation Webinar – Free Download

In addition, anyone that purchases the 510k course will also receive access to our 510k templates electronically in the same dropbox folder.  I recently added a full set of templates for a 510(k) pre-submission request as well.

 

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