This is a webinar 510k course series consisting of 24 webinars, an ebook and electronic templates for your next 510k submission.

Buy the 510k course series for $995

510k Course Webinar Series

This is a webinar 510k course series consisting of 24 webinars, an ebook 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: $995.00

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 – only available through on-line course or 510k workshops
2. Vol 15 – Biocompatibility – $79
3. Vol 5 – 510(k) Summary – $79
4. Vol 19 & 20 – Animal & Clinical Studies – $79
5. Vol 11 – Executive Summary & RTA Checklist – $79
6. Redacted FOIA 510k Webinar – $79
7. FDA Declaration of Conformity (Form 3654) Webinar – Obsolete, no longer required by FDA.
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 510(k) Submission – $19
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.