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We hired a consultant to help put together the paperwork and deal with the actual submission itself. They did not support us on putting our documentation together, and could not pr…

There is also a very high overhead required for simply getting products to market. When the easiest way to proceed is by hiring high-priced consultants who hold all the keys, it ma…

Our 510k is definitely a sliver of the various forms of requirements that may be needed depending your product space and classification. We're hoping this repo will grow as other c…

Agreed. We'd like to expand fom just FDA specifically (and 510k specific), and get into maintaining quality standards. There are numerous different segments you can expand to as we…

We don't have any experience with food and supplements with the FDA, so don't have a lot to offer. The hope is that based on your experiences, you could contribute to github.com/Sh…

Alex, happy to help. First thing would be to review our 510k documents we made available on the github repo, and see if there are any specific gaps. Start a conversation and submit…

Hello! I'm CTO of Shift Labs. Happy to answer anyone's questions about making the FDA process more accessible to startups.

Shift Labs (YCW15) is looking for our first embedded systems hire in Seattle. We’re a Y Combinator backed company creating innovative and simple devices for fast-growing healthcare…

Embedded Systems Engineer | Shift Labs (YCW15) | http://www.shiftlabs.com | Seattle, WA Help change medical devices. We're looking for an immediate electrical engineer with embedde…

This may just be a result of their maturity. The YC companies may seem "not very good" because they're closer to market and practical application. When it comes to research, partic…

Functionality will not be made less of a priority, but we are making design and usability equally as important. Doing so helps cut down on training and support required for equipme…

Thanks for reaching out! AsthmaMD looks like a great product. Would love to connect in the future.

The device does not currently have the CE Marking, but it is something we recognize as very important to sell in certain markets. We're working on it!

Thank you! Every day we wake up wanting to work towards a better healthcare solution. There are many ways to solve it, and this is just one of many, but we feel this is where we ca…