We're looking for a remote fda 510k consultant who can help us with medical device 510k submission advice and iso13485 certification. In terms of requirements, we're already taking on board advice to help us get through regulatory hurdles with the tga and ce marks and are fully aware of our requirements and on the way to getting our technical file ready. Our devices are class 2 devices: -a device which converts any bed into a hospital bed (with motors and a frame that adapts to your current bed) -one which monitors movement patterns and vital signs non invasively, as you lay on it. Our app takes in inputs from this, and, perhaps, in the future, other devices too and processes them into alerts that are sent out to loved ones/caretakers. Both are a fraction of the price of current offerings, and aimed at a b2c market. To qualify, please provide your feedback on the following. -have you worked with fda 510k submission in the past? -have you worked on ce marks/tga and other regulatory bodies globally too.
I have done both - I've established a complete ISO***** QS and written, submitted and gotten product...14.9 Days Later
William |VP, Regulatory, Clinical and Compliance
Yes, I was trained by the FDA on How to Review 510(k's), brought TUV PS now Sud to the FDA to be the...14.9 Days Later
John |Founder and Managing Director
SUMMARY ***** practical professional with extensive VP/Director level experience. Expertise i...14.9 Days Later