Latest FDA Changes to the Process Bullet Proof 510k - 2017
Mon, Jul 24, 2017 10:00 AM (PDT)
Online,
Fremont,
California
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Mon, Jul 24 - 11:00 AM
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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=ticketprinting_Jul_2017_SEO
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=ticketprinting_Jul_2017_SEO
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