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Study Group Explores Networked Medical Device Risk Management

There were about 25 attendees today; mostly regulatory, quality and security experts along with a few representing hospitals, and a connectologist or two. We ran from 11am until almost 7pm. (You can read my run up to this meeting here.)
As security expert and clinical engineer Steve Grimes noted, we are an industry in transition with […]


Regulatory Bodies Contemplate Regulating the Deployment and Use of Networked Medical Devices

I’m on my way today to an interesting meeting being held at FDA offices in Rockville, MD. The regulatory groups ISO TC210 and IEC SC62A are convening a formal study group to look at safety requirements relating to installation, configuration and maintenance of networkable medical devices. This is a two day meeting and I’ll be […]


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