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

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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.


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


Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
Disclaimer: ourGlocal is an open academical resource system, which anyone can edit or update. Usually, journal information updated by us, journal managers or others. So the information is old or wrong now. Specially, impact factor is changing every year. Even it was correct when updated, it may have been changed now. So please go to Thomson Reuters to confirm latest value about Journal impact factor.