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
Medical Device Labeling And Compliance
Looking for a subject matter regulatory expert for fda 510k medical device labeling on pouches, secondary packaging, primary packaging and dfu requirements. Need to review labels and content.+11 Other Responses