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Site language : English - Français
Ref : 25463
Event :Latest FDA Changes to the Process Bullet Proof 510k - 2017

Date :Tuesday July 25th, 2017

Location :Online (Internet, Videoconferencing, ...)

Type :Education - International audience

Accreditation :--


 

Further information

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

Full Details & Registration Link:

http://www.compliance4all.com/control/w_product/~product_id=501323LIVE?channel=doctorama_Jul_2017_SEO

Further information

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Announcer

Compliance4All
Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations. These services help them to be compliant with regulatory requirements. . Compliance4All [...]

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Details

Latest FDA Changes to the Process Bullet Proof 510k - 2017 Pharmacy - Medicine - Bio-Technologies - Management - Public Health
bullet proof 510k, quality system regulation, 510k process, fda 510 k submission, 510k medical device, fda 510k approval, 510k submission, medical device marketing
Professionals, How to Prepare Submissions 510(k) Submission Methods
100 1 --
English

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