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Archives for August 2016

Medical Internet of Things (IBM): Creating and Deploying Connected Medical Devices

It was a treat to feature IBM’s Kimberly Cobb at this year’s 10x Medical Device Conference.

Kim finds manufacturers who say, “We don’t want to be a medical device company any longer, we want to be a services company. We want our services to drive the demand for our devices.”

Are you among them?

Click for the transcript and slides. »

The Theranos 483s: What We Can Learn

David Amor, MS, CQA, principal at his firm Medgineering, kicked off the 2016 10x Medical Device Conference with a riveting talk about the Theranos 483 warning letters.

It was also a courageous talk – Former Theranos employees refused to give a presentation for fear of litigation and reprisals from the company.

David covered what a warning letter or 483 remediation project is, what a quality deficiency is, and how you can resolve them in a positive collaboration with FDA.

I also invited David back to present (with Jon Speer from greenlight.guru) at the 10x Medical Device Conference for 2017, our fifth annual event. Prices are deeply discounted this far ahead of the event if you’d like to register. (Full refunds until Valentine’s Day.)

Click for the transcript and slides. »