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Guidance on Software and Device Changes and the 510(k)

Start Date:
Monday, 30 October, 2017
End Date:
Monday, 30 October, 2017 11:30am
Health & Nutrition

Overview: The first guidance document clarifies key terms and provides insight as to how a risk assessment can help medical device manufacturers to evaluate whether a new 510(k) is required. Why should you Attend:Anyone who is involved in software and device design, modification, manufacturing, quality testing and distribution should be aware of these changes and the impact on decision-making as to whether or not to prepare a new 510(k).

The FDA provides flowcharts that guide the reader to the best decision, but some judgment is also required. Areas Covered in the Session:Medical Device changesSoftware Application changes for software used in conjunction with medical devicesFDA Guidance DocumentsFDA EnforcementNew 510(k) submission Who Will Benefit:Information Technology (IT) AnalystsIT DevelopersIT Support StaffQC/QA Managers and AnalystsClinical Data Managers and ScientistsAnalytical Chemists Speaker Profile:Carolyn (McKillop) Troiano Carolyn Troiano has more than 35 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries.

She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs. Contact Detail:Compliance4All DBA NetZealous,Phone: +1-800-447-9407Email:


161 Mission Falls Lane,
Suite 216

Organizer Details

Conference organized by Netzealous LLC DBA - 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.

Netzealous LLC DBA - Compliance4All

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