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. +20 Other Responses
We are looking for partners in us who take care of fda c-1,2,3 and 510k and clinical trial. We have many customers who need the services. If of interest please contact me via zintro.+14 Other Responses
Need a special 510k written for a class ii device that includes hardware. Will also need new risk analysis, design controls, testing, and procedures written for bench testing. Looking for pricing, even if it is estimated.+20 Other Responses