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

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Category Technology, Engineering, Performance

Deadline: August 29, 2017 | Date: August 30, 2017

Venue/Country: Fremont, U.S.A

Updated: 2017-08-18 16:31:26 (GMT+9)

Call For Papers - CFP

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: supportcompliance4All.com