A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to PMA.
Why should you Attend:
This includes any major change or modification to the intended use of the device that could have an impact on patient safety and effectiveness. After attending this webinar, you will be able to better navigate the processes required to determine how to manage software and device changes in an FDA-compliant manner.
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
Quality Managers, Chemists and Microbiologists
Compliance Managers and Auditors
Lab Managers and Analysts
Carolyn (McKillop) 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. Carolyn is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area.
Event Fee: One Dial-in One Attendee Price: US $290.00
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