Boston Professional Events List

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

Oct 30, 2017 - 10:00 AM
Netzealous LLC DBA - Compliance4All
Netzealous LLC DBA - Compliance4All,

ZIP: 94539
Phone: 18004479407

Ticket Price: $ 150.00
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
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: [email protected]   

Event Categories
Keywords: Educational, software , medical


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