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Latest FDA Changes to the Process Bullet Proof 510k – 2017

July 25 @ 10:00 am - 11:00 am

$150

Overview:
The Special and Abbreviated 510(k) methods were developed under the “New 510(k) Paradigm” to help streamline the 510(k) review process.

Objectives:
Know the differences between the Traditional, Special and Abbreviated submissions
Understand Substantial Equivalence and how it is applied
Who is required to submit the application to FDA

Who Will Benefit:
This course is appropriate to those involved in all aspects of the premarket notification, i.e., 510(k) process on behalf of medical device and In Vitro Diagnostic manufacturers.

Speaker Profile:
David R. Dills,Global Regulatory Affairs & Compliance Consultant currently provides regulatory affairs and compliance consultative services for early-stage and established Class I/II/III device, IVD, biopharmaceutical, cosmetics and nutraceutical manufacturers on the global landscape.

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: support@compliance4All.com

Details

Date:
July 25
Time:
10:00 am - 11:00 am
Cost:
$150
Event Categories:
,
Website:
http://www.compliance4all.com/control/w_product/~product_id=501323LIVE?channel=jamaicaplainnews_Jul_2017_SEO

Venue

Online
Online
Framingham, MA 01701 United States
Phone:
508-877-7630, ext. 3303
Website:
http://newenglandwild.org/learn/our-programs/certificate-orientation-webinar

Organizer

Compliance4All
Phone:
18004479407
Email:
support@compliance4All.com
Website:
http://www.compliance4all.com

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