Medical Device Changes, the 510(k) and FDA's Two Guidance Documents on Device and/or Software Changes

By: John E Lincoln ,Principal of J. E. Lincoln and Associates LLC.

Deciding When to Submit a 510(k) for a Change to an Existing Device

  • 24-March-2020| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 60 Minutes

Exporting to Mexico Procedures and Documentation

By: Jan Seal ,International Trade Consultant.

Preventing errors that could result in severe civil and/or criminal penalties

  • 28-April-2020| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes

EU Medical Device Regulation (MDR 2017/745): Latest Update and Approaching Deadline

By: David R. Dills ,Director of Regulatory Services at CROMSOURCE.

Plan an efficient transition and understand the most critical lessons to prepare for this transition

  • 25-March-2020| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes
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