Developing premarket approval packages for innovations which are more effective in reducing potential adverse events; MAUDES; and or recalls particularly FDA class recalls

By: Dr. George Yanulis ,Medical Device R&D Engineer.

Premarket Approvals Premarket approval (PMA) are required by The Food and Drug

  • 13-November-2019| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes

The Validation of Non Product Software

By: Thomas Bento ,Sr. Regulatory Consultant.

How to comply with 21 CFR Part 820.70(i) and effectively implement a software validation

  • 10-December-2019| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 60 Minutes

Navigating the 510(k) process

By: Thomas Bento ,Sr. Regulatory Consultant.

Simplified defensible approach to a successful submission

  • 12-November-2019| 12:00 PM ET | 09:00 AM PT | 11:00 AM CT Duration 60 Minutes
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