George H.
Regulatory Affairs Specialist for Medical Devices
I have successfully obtained over 70+ 510(k) clearances from the FDA for a vast range of medical devices. I can assist you with your 510(k), De Novo, Q-Sub (Pre-Sub), or IDE submissions, along with any other medical device documentation needs. I am also very experienced in helping to register and list Class 1 exempt medical devices with the FDA. I am insured, and I can guarantee that you will be satisfied with the value that I provide or you won't be charged. I can also help you with On-Line Training, Process Validation, Design Control Activities, Document Creation and Review. Lastly, I can provide sound advice and answers to your regulatory concerns and questions based upon my over 25 years of experience. My business model is built upon being fast, good, and satisfying clients! Please allow me to become your Trusted Advisor.
Earnings and projects
Last 6 months ÷ 6
Last 6 months: $2.4k
Billed in all: $83,781$84k
$488 in the last 6 months
Across 7 contracts
Across 119 contracts
Earnings, last 30 days
Skill rankings: Top 17% in Technical Writing
Ranked by MRR among everyone on Upwork with the skill.
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