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

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 changes
Software Application changes for software used in conjunction with medical

devices
FDA Guidance Documents
FDA Enforcement
New 510(k) submission

Who Will Benefit:
Information Technology (IT) Analysts
IT Developers
IT Support Staff
QC/QA Managers and Analysts
Clinical Data Managers and Scientists
Analytical 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: +1-800-447-9407
Email: support@compliance4All.com
At a Glance
When 30 October 2017
Where Fremont, CA, United States
Organizer Netzealous LLC DBA - Compliance4All
Event Type conference
Official Website
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Added by Compliance4all
Added on 09 August 2017
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