Columns & Articles

Topic	Date
510(k) Substantial Equivalence In Plain English - Part 1 PDF [Part 2 will be out in two weeks.] Listen to the podcast Simplifying Substantial Equivalence In FDA Premarket Notifications	Sept. 12, 2014
Biomedical nanotechnology: The smaller the thing, the bigger the challenge (HealthCare Packaging) PDF	Aug. 25, 2014
Everything You Know about Materials Is Wrong (Qmed) PDF	Aug. 15, 2014
Panel discusses legal, ethical concerns of 3D printing (American Bar Association Annual Meeting) PDF	Aug. 8, 2014
Is Your Boring Regulatory Strategy Costing You Business PDF	Aug. 2014
Guerilla Regulatory Strategy (MED Device Online Regular Contributor)
Take Control Of Your Medical Device's FDA Classification (MED Device Online) PDF	Jul. 2, 2014
How to Sharpen Your Regulatory Sword (MDDI) PDF	Feb. 11, 2014
3 Tips To Vastly Improve Your FDA Communication Strategy (MDDI) PDF	May, 2, 2014

Please connect with me on LinkedIn to be notified of future events.