We are looking for us-based consultant who can help us conduct a review of our current 510k, evaluate the need for a supplemental 510k given the incremental changes since 2016 release.
-develop plan and outline of work required for supplemental 510k
-gather required documentation and submit to fda
-remediate questions until completion.
To qualify, please provide your feedback on the following:
1. Describe your experience with 510k submissions.
2. Describe key parts of a 510k submission
3. What challenges have 510ks presented you in the past? How did you overcome them?
4. What device class (i,ii,iii) does your experience include?+26 Other Responses
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
Fda Approval Process
I am in the process of partnering up with a design/manufacturing facility to get my device to a design freeze and subsequently through all the processes to fda approval via 510k filing. I am in need of a consultant just to guide me through the process and help me out with this collaboration to ensure i do not make any mistakes when dealing with such a company. +18 Other Responses