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: [email protected]

Others Details

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