Latest FDA Changes to the Process Bullet Proof 510k - 2017
- Start Date:
- Tuesday, 25 July, 2017
- End Date:
- Tuesday, 25 July, 2017 11:00am
- Health & Nutrition
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: +1-800-447-9407Email: support@compliance4All.com
161 Mission Falls Lane,
Conference organized by 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 has a panel of acclaimed Experts whose professional trainings help regulatory professionals and organizations in a number of ways and take them to their goal of meeting regulatory requirements. Compliance4All offers path breaking professional training solutions to organizations that help them address pain areas and overcome the challenges and difficulties associated with meeting regulatory requirements.
- 161 Mission Falls Lane, Suite 216