I am developing a class II medical device and I am looking for a person to assist me with the FDA 510 (k) Submission process. I am able to do a lot of the 'heavy lifting' but would greatly appreciate someone to provide executive oversight.
Ideally you will be able to demonstrate that you have successfully assisted other organizations in achieving 510 (k) clearance.
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I have briefly read the description on IOS/Android development, and I can deliver as per the requirements however I need us to discuss for more clarity on the details, deadline and budget as well.