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
New 510(k) submission
Who Will Benefit:
Information Technology (IT) Analysts
IT Support Staff
QC/QA Managers and Analysts
Clinical Data Managers and Scientists
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.