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
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.
The following webinars are already recorded an available for immediate download from our 510k course dropbox folder (individual pricing shown below):
- How to prepare your 510k in 100 days – only available through on-line course or 510k workshops
- Vol 15 – Biocompatibility – $79
- Vol 5 – 510(k) Summary – $79
- Vol 19 & 20 – Animal & Clinical Studies – $79
- Vol 10 – Executive Summary & RTA Checklist – $79
- Redacted FOIA 510k Webinar – $79
- FDA Declaration of Conformity (Form 3654) Webinar – $49
- Sterilization Shelf Life Webinar – $49
- How to Complete a 510k Cover Letter Webinar – $29
- Labeling & UDI 510k Requirements Webinar – $49
- Device Description Webinar – $29
- De Novo Application – $49
- Small Business Qualification Fee for 510(k) Submission – $19
- 510k Hardware & Software Documentation Webinar – $129
- 510k Project Management Lessons Learned Webinar – $129
- How to Combine a 510k Submission with CE Marking and Reduce Your Workload by 35% – $129
- FDA Pre-Sub Meetings – $129
- 510k Submissions: Predicate Device Selection – $129
- 510k Submissions: Substantial Equivalence – $129
- 510k Submission Section 4: Indications for Use – $129
- 510k Project Management Webinar – $129
- How to complete Section 6, 7 and 8 of a 510(k) Submission – Free if you submit a question
- FDA eCopy Print & Ship Webinar – Free if you submit a question
- 510k FAQs Webinar – Free if you submit a question
- 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.