2018 FDA Guidelines for 510(k) Submission

By: Dr. David Lim Ph.D., RAC, ASQ-CQA ,President and Principal of Regulatory Doctor.

Process leading to timely clearances

  • 11-July-2018| 01:30 PM EDT | 10:30 AM PDT | 12:30 PM CDT Duration 60 Minutes

ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

By: Mike Colvin Ph.D. ,Medical Device Consultant.

Overview of ISO 10993-1

  • 29-June-2018| 12:00 PM ET | 9:00 AM PT | 11:00 AM CT Duration 90 Minutes

Data Integrity – FDA’s Latest Thinking

By: Angela Bazigos ,CEO Touchstone Technologies Silicon Valley.

Data be reliable and accurate.

  • 30-November--0001| 12:00 PM ET | 9:00 AM PT | 11:00 AM CT Duration 180 Minutes
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