Newsletter | December 19, 2019

12.19.19 -- Med Device Online Top 10 Of 2019


It’s time to close the book on 2019. Our last newsletter of the year, this edition reflects on the most popular content published in the Med Device Online newsletter in the past 12 months. This year, we welcomed a new FDA commissioner, wrung our hands over the EU’s MDR and IVDR, and strove toward quality systems both ambitious and attainable.

Our aim at MDO is to build and improve upon that coverage from our first newsletter of 2020. Have a safe and joyous holiday season ahead, and tell us what's on your mind — whether it’s what you want to see in our coverage or how you can contribute. Get in touch with Med Device Online at

Top 10 Featured Editorial
  1. What Happens To ISO 13485 When Annex L Is Adopted?
    By Mark Durivage, Quality Systems Compliance LLC
  2. A High-Level Overview Of The Proposed Rule To Align FDA’s QSR With ISO 13485
    By Marcelo Trevino, TregMedical Compliance Services
  3. The European MDR: Impetus, Impacts, And Current Status
    By Zaid Al Nassir, Decision Resources Group (DRG)
  4. Raising The Bar: The Silver Lining Of FDA Commissioner Gottlieb’s Exit
    By Nancy Bradish Myers, Catalyst Healthcare Consulting, Inc.
  5. Will We Have Harmonized Standards By The MDR’s Date Of Application?
    By Leonard Eisner, Eisner Safety Consultants
  6. How To Write An Effective Validation Master Plan
    By Joy McElroy, Maynard Consulting Company
Top 10 Industry Insights
  1. Preparing For MDR? Start With A Gap Analysis
    By Mark Cabonce, WuXi AppTec
  2. The Criticality Of Process Validation
    By Todd Owens and Raghu Vadlamudi, Donatelle
  3. An Introduction To Vacuum Decay Leak Testing
    By Oliver Stauffer, PTI Packaging and Inspection Systems
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