I'm a RA consultant, seeking an experienced RA Advisor to look over my shoulder as I take Client's medical device to market in U.S.. So, need an Advisor w strong experience in commercialization, product development (software, esp). No actual 'work' to do.....just maybe look over my shoulder and let me know if I'm on the right track, or not. I'm familiar with the FDA processes, but no expert. I can handle the QMS part myself. We're going w Class I now, moving to Class II within a year. Diagnostic medical product, early stage co.
That's all. Maybe we'll just chat on the phone a couple times a week, and I'll share what's going on. Or we can do email if u prefer to read.
I'm here at iso13485clarity.com
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Kevin McLellan
Owner
Memphis TN
United States
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