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

Event Details

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

Time: October 30, 2017 from 10am to 11:30am
Location: Online
Street: 161 Mission Falls Lane, Suite 216
City/Town: Fremont
Website or Map: http://www.compliance4all.com…
Phone: 8004479407
Event Type: webinar
Organized By: Adam Fleaming
Latest Activity: Aug 16, 2017

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Event Description

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

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