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akehrer

akehrer on Hacker News

Re:Ask HN: What is something you built but never marketed? on Sunday August 14, 2022 @04:03PM (#32462435)
https://helpmeetcal.com/

A webapp for creating calendar events with unique links to meet.jit.si for video conferencing. It was an early pandemic project that I haven’t done anything with since putting it up.

Re:Detecting unauthorized physical access with beans, lentils and colo... on Monday June 27, 2022 @09:58PM (#31903274)
Maybe use injection mold resin pellets instead. They’re not as convenient as rice or lentils, but there are a lot of color choices.
Re:The Magic of a Cardboard Box on Monday June 11, 2018 @02:40PM (#17287095)
We have a few of #2 we got from Amazon. You can still cut yourself but it's more of an abrasion than a laceration. It's great when you can find real tools for your kids to use and explore their ideas independently.
Re:The Magic of a Cardboard Box on Monday June 11, 2018 @12:31PM (#17285751)
We've found that box cutters like these[1] work great and are safe for even our six year old to use.

[1] http://www.canary.jp/canary-en/item/en_11_dan.htm

Re:George Hotz cancels his Tesla Autopilot-like ‘comma one’ on Friday October 28, 2016 @01:40PM (#12818586)
He's got two weeks to provide the detailed information he should already have or a reason why he doesn't have it. He could even provide an estimate (see instruction #4 in the Special Order). The threat of legal consequences is if any information/reason is missing or if the order is completely ignored. Getting your company shut down by the government only comes after a lot of back and forth communication and is usually due to willful negligence on the company's part.
Re:George Hotz cancels his Tesla Autopilot-like ‘comma one’ on Friday October 28, 2016 @12:46PM (#12817958)
Why do that when you could just get the information directly from the NHTSA [1]? I expect all those companies have been in communication with regulators from the beginning and produced plenty of documentation. Besides, they can't do the same thing the large players did since they aren't in control of developing the entire vehicle.

[1] http://www.nhtsa.gov/nhtsa/av/av-policy.html

Re:Introducing Startup FDA: Demistifying FDA submissions through Open ... on Thursday May 19, 2016 @05:59PM (#11734207)
Have you thought about including redacted copies of 510(k) submissions available from the CDRH FOIA Electronic Reading Room [1]? You could probably just provide a list of links to the PDFs.

Here's an example of one for a powered laser surgical instrument (warning: 57MB PDF):

http://www.fda.gov/downloads/AboutFDA/CentersOffices/Officeo...

[1] http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/read...

Re:Introducing Startup FDA: Demistifying FDA submissions through Open ... on Thursday May 19, 2016 @04:31PM (#11733553)
First of all, thank you Shift Labs for putting up their information and helping make confusing regulatory processes clearer.

Secondly, I want to let people know my company[1] works with many start-ups in the medical device space that are developing regulated products, both 510(k) and CE mark. We are engineers that understand the regulatory process not just regulatory consultants.

If anyone is interested feel free to contact me [email protected].

[1] http://www.in2being.com/

Re:A Truck the Russians Make for $50K on Thursday February 11, 2016 @01:02PM (#11081743)
Which reminds me of the Fordson Snow Machine https://www.youtube.com/watch?v=rn5jkXEFTZ4
Re:Laser Razor suspended by Kickstarter on Tuesday October 13, 2015 @12:47PM (#10381680)
If Mr. Gustavsson is involved I wonder why there's no mention of the regulations they need to pass before they can sell units in the US. I did a quick search [1] and found a few of the systems he has been involved in and they are all FDA Class II devices which is a long, involved process. They'll need data showing substantial equivalence to a predicate, unless they've come up with a way to get around the FDA. At a minimum they'll have to register as a laser product with CDRH before they can ship anything. [2]

[1] http://pathsurveyor.com/510k/K013366 [2] http://www.fda.gov/radiation-emittingproducts/electronicprod...

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