Boston Professional Events List


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


Date
Jul 25, 2017 - 10:00 AM
Organizer
Netzealous LLC DBA - Compliance4All
Venue
online
Location
Netzealous LLC DBA - Compliance4All161 Mission Falls Lane, Suite 216,Fremont, CA 94539, USA. Phone: +1-800-447-9407Email: [email protected],

Fremont,
CA,
US,
ZIP: 94539
Phone: 18004479407

Ticket Price: One Dial-in One Attendee Price: $150.00
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: [email protected]

Event Categories
Keywords: Educationa




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