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

Website http://www.compliance4all.com/control/w_product/~product_id=501323LIVE?channel=ourglocal_Jul_2017_SE | Edit Freely

Category Bullet Proof 510k, Quality System Regulation, 510k process, fda 510 k submission, 510k medical device, fda 510k approval, 510k submission, medical device marketing, medical device consulting, fda 510 k database

Deadline: July 24, 2017 | Date: July 25, 2017

Venue/Country: Online, U.S.A

Updated: 2017-05-16 20:30:59 (GMT+9)

Call For Papers - CFP

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: supportcompliance4All.com