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How to validate a market with development boards and SD cards
- negative_zero 2y agoEEE here with 16 years experience and having to deal with compliance from day 1 of my career. I now consult on product compliance. Author you are welcome to contact me. Disclaimer: Nothing below is meant as legally relevant compliance advice. This is just my opinion on the matter. Going to snark: "The testing and certification industry is odd" Except, outside the software world, the real world, where there are real consequences, it's not really. "The line about CES, in particular, made my hair stand up." Why? Absolutely the unauthorised device at CES is should NOT be allowed. What if said device caused too much interference on cell phone frequencies and suddenly nobody at CES can dial the local emergency number? If that made "your hair stand up", here's one from personal experience that will freeze your blood: I worked as a teen for a certain electronics chain. Said chain was selling a wireless weather station imported from China. A government department that monitored the country for Earthquakes noticed that this device impinged on their frequencies. After the spectrum regulator confirmed the finding, a nice gentleman from them visited us a told us the following: 1) As of this moment this device can no longer be sold. Move it off the floor immediately (he stayed and made sure we did exactly that). 2) That we will immediately issue a recall of said device at your own cost and issue full refunds to the customers. 3) He will return when we decide on further enforcement action which may include punitive fines and recommendations for further remedial action you will need to undertake. "In theory, it exists to serve the public good and uphold consumer protection laws." Well here's a (very simplistic) tidbit for the author: In the US, part of the gestation and formation of standards bodies and testing was "market forces", not for the public good. It was to help protect companies from litigation. If you followed the standards, tested and certed to them, paid the fees etc you then had the standards entity bat for you in court (UL is short for Underwriters Laboratory. That name was not chosen for funsies). "However, in reality, the labs are “too busy” to respond or reply very late and generally sound less than eager to work with you." Well you don't sound like a serious customer. AND the Labs are not there to give you advice. They're there to do INDEPENDENT testing. "Variations of the FCC exist in pretty much every developed economy. Putting a poorly tested hardware product on the market immediately puts a target on your back. Maybe you’ll get lucky, but chances are that someone somewhere will report you. And, unless you are operating entirely out of China, it will hurt. A lot. Both your company and maybe even you, personally." As it should. The electromagnetic spectrum is a very precious and very limited commodity and IMO, the best regulated "commons" in human civilisation (though still not perfect). So no, you are not welcome to just urinate in it willy nilly with your hustler start up product. "I did not want to spend so much money on testing before I validated the market or gathered a community of believers." And there it is. "This way, the electronic device liability will fall on the manufacturer, and the magic of friendship EULA should afford me enough protection to make this a pure software play." No. That's not how this works. 1) I assume the author is from the US (as they speak about the FCC). I had a 30 second look at these dev boards and their instructions. There is no FCC conformity declarations or markings, so US customers can't use it. 2) It has CE and UKCA though, so customers from EU+UK (and some other countries) can buy them but the certs only cover the dev boards AS SOLD. (i.e without the authors software) 3) Author is modifying the product behavior with their software. So yes author. You are still liable. Technically, your customers are first in the line of fire. But the likely sequence of steps is: Friendly Spectrum Representative will visit them first, have a chat, ask them to stop using the device, then leave them a lone and then come for YOU. 4) What the author has actually done is "buy down" their risk. It is simply less likely that the product will become non-compliant when their software is loaded. But it is still possible. At second glance, those dev boards don't come with a power supply. What is your recommended power supply to use Author? Have you tested your setup with said power supply and have test reports at the ready for when Friendly Spectrum Person comes knocking? 5) Sure it seems clever but Friendly Spectrum Agencies actually have quite far reaching and scary powers. Don't think that your little sleight of hand here is clever and protects you. Fundamentally: You are repackaging + modifying an existing product. The steps you are taking in between to "launder" your liability are irrelevant. Frankly, it's shit like this, that makes it harder for everyone else playing by the rules. It did actually used to be easier. There used to be exemptions for "low volume" products. But all of those were seen as loopholes and HEAVILY abused. Now these toys have been taken away, with more to follow.
- ThrowawayTestr 2y agoAbsolutely amazing response. I love it when a real engineer comes and explains the real world to software "engineers".
- liminalsunset 2y agoI think that both sides (SW and HW) can learn to coexist better, and tbh, there is really a necessity for them to. The reality is that the reason software is currently the top industry/value creator when it comes to revenue is an artifact of an open ecosystem where the barriers to entry are low, and where there is space for many to experiment. Traditionally, the engineering world doesn't see things the same way. Part of this is culture, and that's hard to change - engineers see what they do as an art, and this is fine,and it's a good thing as some engineering systems do have a disproportionate impact, but I think the tone of the response also does reflect an attitude of perfectionism and "this at any cost" that I think holds the field back. I think the solution is not rather to "just let people run amok" (though as it happens, this is the strategy China is testing for us and it appears to not have broken too much yet - the land of trillions of SOIC-8 Bluetooth MCUs with no shielding and a 5-line BOM) but rather for the engineering world to embrace the software developers and provide a happy path to compliance. If you want North America to compete with China on having ubiquitous technologies everywhere (this is the only way to build out the supply chain), we have to come up with a way to fix certification and part of the attitude has to be "we're going to teach you how to cheaply get your product to market in a way that respects the spectrum", and not "it's expensive, deal with it". This one is tough for people to accept but we cannot ever go back to stuff being expensive, as the floodgates have already been opened. This is something that the government has to do, probably - provide funding to run (at least, cut down versions of the labs for precompliance) cheaply, put out good resources. Encourage or fund the creation of low-cost and easy to understand paths to compliance. As anyone knows, if you try to hold your nose to stop a nosebleed, the blood just goes down your throat. Same with all of the stuff from China. If you want to meaningfully improve device compliance, making the process hard and painful will just increase the number of random Amazon/Temu Bluetooth nonsense with a total lack of attention to design at all. If we made the process more accessible, it's possible that this would drive the industry to create solutions that might not even cost more, but are more compliant - which would be a win overall.
- rererereferred 2y agoTheir FAQ here[0] explain some things about these devices they are building, except for the main question: what are they for? It says personal computers but no audio, video or games. So for reading? [0] https://flyingcarcomputer.com/posts/a-new-personal-computer/ https://flyingcarcomputer.com/posts/a-new-personal-computer/
- chrisldgk 2y agoReading this, it doesn’t seem like they’re really doing anything more than building a glorified raspberry pi with their own self-spun BSD distro preinstalled. Also the FAQ being mostly Q: „why not use X?“, A: „I don’t know X and thus it’s bloated/I don’t like it“ doesn’t inspire a lot of confidence. I admire their dedication and it seems like a fun project. I don’t think it’s something a lot of people will pay money for though.
- sgerenser 2y agoLooks very weird. No LCD screen, but presumably it’ll plug into a monitor? Seems like just pointing out expected use cases would go a long way.
- biosboiii 2y agoThe FAQ is hilarious. He is writing this entire article to save 3-5k conformity tests, but bases his entire software on FreeBSD because "it's more commercially friendly.
- buescher 2y agoThis new type of personal computer runs... xlib and twm. I like this person, but, uh, I'm not investing.
- Joel_Mckay 2y agoYou do know many devices like Raspberry CM have FCC/IC modular pre-compliance, and thus usually only require LAB EMI testing under the rules. The primary problem with mystery-parts is they tend to have issues with RoHS documentation, complex customs clearance requirements, and unknown specifications. DIY evaluation kits people assemble do fall under a sort of gray area, but if your hardware does splatter the RF spectrum it is a $1m fine in the US, and a $5k fine + up to 5 years in jail in Canada. Unshielded RAM, USB/PCI to Ethernet, and Video GPU chips will often just barely pass EMI testing under ideal circumstances. Cheap stuff from the mystery bins will usually just glean the FCC id off a refrigerator to get through customs. Have a nice day, =3
- practicemaths 2y ago"The testing and certification industry is odd. In theory, it exists to serve the public good and uphold consumer protection laws. On the other hand, its customers are in the private sector. Normally, market forces would dictate that by now it would be straightforward, fast, and affordable to get your product tested as frequently as desired. However, in reality, the labs are “too busy” to respond or reply very late and generally sound less than eager to work with you. Not to mention, the fees that they quote are rarely palatable to a bootstrapping startup. And yet, working with them is generally required to get your product to market." Market forces naturally determined this outcome though. If you're big companies you naturally want to limit the threat of new competition. Making compliance more costly achieves this.
- eYrKEC2 2y agoa.k.a. "regulatory capture" - https://en.wikipedia.org/wiki/Regulatory_capture https://en.wikipedia.org/wiki/Regulatory_capture
- bildung 2y agoEnforcing basic device safety is hardly regulatory capture. I was part of preparing devices for CE tests, the requirements are essentially: nobody gets killed if the hardware is plugged in, you haven't accidently created an rf transmitter, and if you want to advertise IP67 it should survive being placed under water.
- taneq 2y agoAlso, by definition, testing and certification companies have a captive market and will tend towards being lazy and exploitative. Any competition that springs up might temporarily improve things but then it too will get used to having a captive market and start sliding in the same direction.
- tootie 2y agoI used to work at a place that did some custom hardware development. Usually one-off or very limited run. Any time we fabricated a case and plugged in off-the-shelf devices, certification was not necessary. If we did custom wiring we got ETL certified. I didn't run the process myself but I recall it being easy and not very costly (few thousand?) It's a barrier but a pretty low one. Our electronic work was like advanced amateur level and it still passed with minimal modifications.
- analog31 2y agoIs there such a thing as low-cost testing and certification services operating overseas?
- miki_tyler 2y agoThat's a TERRIFIC idea and a great business model.
- analog31 2y agoActually, I'd use such a service myself.
- Aurornis 2y agoThere are labs in China that will wink wink pass any product you send them for a flat fee. The problem is that having passing test results from a random lab doesn’t help you if the FCC (or one of your competitors) discovers that your device is not actually compliant. So you have to be careful about what you’re getting.
- jkestner 2y agoYes. The FCC has a list of accredited testing labs here: https://apps.fcc.gov/oetcf/eas/reports/TestFirmSearch.cfm https://apps.fcc.gov/oetcf/eas/reports/TestFirmSearch.cfm Many are in China and have reasonable prices.
- liminalsunset 2y agoThere are plenty of products which ought to be certified but are not, and plenty of products that probably do not need to be that are. This is across large and small companies, so I'm going to take a guess and say that in the AliExpress and Temu age, simply mailing the device from China will solve all of your problems.
- Aurornis 2y ago> so I'm going to take a guess and say that in the AliExpress and Temu age, simply mailing the device from China will solve all of your problems. Your guess would be wrong. The regulatory agencies aren’t inept. They’ll figure out where the headquarters is, not just where the products are being shipped from. So unless you’re moving the entire company, and your bank accounts, to China and you have a backup plan for what happens when they start seizing your shipments at the border, this isn’t a solution.
- liminalsunset 2y agoDo you actually have an example of something like this actually happening? From what I can tell, at least in Canada, absolutely nothing from China I've bought has ever even been opened for inspection, and it's all tagged as a gift worth ten cents and a battery cover or something inane like that. Anything from half a kilowatt hours of laptop batteries to miscellaneous electronics has passed through, so I don't think there is any inspection going on at all. Anecdotally based on the number of things that I see without any FCC ID (tbf you can abuse the SDoC process which is self declared [this is why the CE certification is worthless btw] ), I'm just uncertain the FCC actually does any enforcement. And Amazon sellers are also an example of this not being an issue.
- HeyLaughingBoy 2y agoYep. Fluke, an electrical instrument manufacturer, has a copyright on the look and feel of its handheld digital voltmeters (DVMs). Anyone in the industry will immediately know a Fluke by what it looks like. And they are pretty much the gold standard of handheld DVMs. Some years ago, a containerload of cheap DVMs from China arrived with a similar appearance, but not made by Fluke. Customs seized the lot and informed them. I forget the details of what happened next, but they were not allowed to be sold in the US since they were in violation of the Fluke copyright.
- jvanderbot 2y agoI never understood the nuance here. If I put a rasp pi in a box, does it need certification? What about with connections soldered on if all connections are already certified? How about the logical next step of a board with certified components?
- deleted 2y ago[deleted]
- TheCleric 2y agoI’m no expert but I think the problem is that once you start combining certified components in a new configuration that it’s theoretically possible for the sum of the parts to be non-compliant. Perhaps a wire you added becomes, in essence, a transmission antenna of the noise in the circuit and thus could interfere with other devices.
- utensil4778 2y agoAs far as I understand, modules like an ESP32 for example, carry their own FCC certification. If you include them in your product, you do still need certification of the product overall, but you don't have to worry about the radio certification, just unintentional radiators. For instance, if your widget includes an ESP32 and a switching power supply, you are (notionally) guaranteed to never fail certification due to bad behavior from the ESP, but if you botch your power supply design and are spewing out noise in the KHz to MHz range, you still fail certification. Even if every individual component in your device carry their own certification, you still have to certify the product as a whole. Poor PCB design can produce bad EMI. Maybe you're running SPI over a long wire or your traces are routed in a way that accidentally creates an antenna at your SPI clock frequency. Hell, even something as simple as toggling a GPIO pin once a second can emit high frequency EMI under the right conditions. There are a lot of ways to unintentionally produce harmful EMI, and that's exactly why FCC certification is required for everything. This stuff is hard to get right and there are endless gotchas and exceptions and edge cases and you have to know about and account for all of them.
- jvanderbot 2y ago
- Animats 2y ago> Market forces naturally determined this outcome though. Market forces alone didn't work. It's an externality, a cost paid by others not involved in the transaction. Market forces don't handle that. A 1970s Milton Bradley Big Trak and a Radio Shack TRS-80, both popular products in their day, will, if brought near to each other, both crash. Without fairly strict regulation of unwanted RF emissions, there would be many incompatible devices. There were before the FCC started requiring more testing in the 1970s. A world with a huge number of consumer devices emitting RF noise would have prevented low-power cellular phone and WiFi deployment. It's not that hard. This is an "unintentional emitter" (it's not trying to send a radio signal). The rules for that are not too bad. Testing costs about $3000 to $5000. You want to have some ability to pre-test. You might find something. Attaching a wire to something can give it an antenna and make it emit much more RF, so you do need to test. It's not too hard.[1] Actual FCC certification is $3000 to $5000, assuming you pre-tested and fixed any problems before getting a certification run. From the project's FAQ: "Given that this will initially be a niche product, the price will be quite high. I was once taught to ask myself the following question: Who is your rich customer? The type of person whom I have in mind has a high discretionary budget for personal electronics and willingness to pay a premium for novel ideas." [1] https://www.nutsvolts.com/magazine/article/low-cost-emi-pre-compliance-testing https://www.nutsvolts.com/magazine/article/low-cost-emi-pre-...
- bruce511 2y agoThe first rule of knowing if a market exists is to define what you are making and then figure out who it's for. Then pitch to that person the benefits of your product. Alas the FAQ page lacks both of these questions. I'm left with no idea -why- I'd buy this thing. What utility does it have? What is it supposed to replace? I think you can stop worrying about the FCC issues with it. You won't sell any of these (at least not with this FAQ page). Your whole "discussion" is technical and doesn't mention utility once. It sounds to me like you're building this because it's fun to build and scratches an itch. But it's not a product, much less requires you to start building and designing new hardware. So well done on at least skipping that investment. If you want to make a hardware product then early about utility first. If it's useful then other things flow from that. Not the other way around.
- joezydeco 2y agoNow, how to get the SD card in the hands of the customer? Mail it to them! I worked on a equipment project for a large restaurant chain about a decade ago. The core application and related assets/recipes/files were all on an SD card. When it was time to upgrade the app or release new seasonal recipes, every store got a new SD card in the mail with instructions to wait for a certain date, power down, swap cards, power back on, dispose of the old card. It was way cheaper to send updates that way than bother with encryption, networking, corrupted disks, etc. A bricked machine lost a hundred dollars or more per hour. If the new card failed, the operator could continue with the old one until a replacement could be sent. One major problem was suppliers always trying to swap to lower cost SD cards, even counterfeit ones (c.f. Bunnie), and things would go south really fast. The Linux system and hardware were both pretty old and had MMC stack issues when the cards showed shaky margins on the timing. Or, capacity wasn't what was advertised (c.f Bunnie). We had to spend a cycle or two qualifying each mailing release to make sure a shitty batch of cards didn't make its way into the stream. SD has its uses, although I still prefer a read-only eMMC partition to hold the bootloader and O/S. I don't get why RPi users put themselves through such misery to save $20 on their SBC.
- zkirill 2y agoGlad to hear that this passed muster in the food industry. Do you by any chance remember how the SD card was packaged or protected from damage while in transport?
- joezydeco 2y agoThey're pretty durable. It can survive in a padded envelope just fine. I've had them in the pockets of my jeans after a washing machine cycle.
- Aurornis 2y ago> Normally, market forces would dictate that by now it would be straightforward, fast, and affordable to get your product tested as frequently as desired. However, in reality, the labs are “too busy” to respond or reply very late and generally sound less than eager to work with you. Not to mention, the fees that they quote are rarely palatable to a bootstrapping startup. The various test labs I’ve worked with haven’t been “too busy” to respond. However, they are generally hesitant to work with people who don’t really know what they’re doing. If you are an engineer with knowledge about the process and who needs a lab to partner with, it’s not hard to get in somewhere. However, if you don’t have the knowledge or experience, the lab might sense that you’re looking for someone to hold your hand heavily through the process. They may be less than enthusiastic to take on a one-off customer who might require an abnormally high amount of communication and hand-holding when they can fill that same spot with a repeat customer who needs nothing more than to book the time at the lab and can show up prepared and ready to go. I suggest teaming up with a local consultant for your first round. Not only will they help you through the process, they’ll have connections and reputation to get you into the labs. The lab fees aren’t extraordinary high for a hardware startup, really. It’s not free, but it’s not much relative to the up front costs of building hardware inventory.
- fellerts 2y agoIn my limited experience, it was the other way around. I had to hold the technician's hand through most of the testing and onboard several technicians due to a staggering amount of employee churn in the test house. What should take an afternoon would take months of intermittent testing at very inconvenient times (night slots). Next time I might just show up outside their door with a sleeping bag and refuse to leave until the tests are completed. Maybe we were the problem and our documentation was insufficient, but we never had a chance to do a "post-mortem" with the test house and learn how we could do better next time.
- deleted 2y ago[deleted]
- negative_zero 2y ago
- Rovoska 2y agoI would be embarrassed to publish this. It is a stunning display of ego and ignorance of how this part of the world works that boils down to the author being too cheap to put in the work and too lazy to understand why regulations exist.
- AnarchismIsCool 2y agoIt's wild to me that everyone here is taking this seriously. This is high school science fair level stuff.
- WhereIsTheTruth 2y ago> I don’t need to sell the development boards. I just have to tell my customers which boards to buy and how to set them up. This way, the electronic device liability will fall on the manufacturer, and the magic of ~friendship~ EULA should afford me enough protection to make this a pure software play. Parasite of the economy, right there
- fxtentacle 2y agoI wonder how much research this person did. At least in Germany, cheap DIY kits are everywhere !!! https://www.pollin.de/p/bausatz-led-wechselblinker-810051 https://www.pollin.de/p/bausatz-led-wechselblinker-810051 German company selling a German-made electronics kits in Germany without CE certification. And they have lots of them: https://www.pollin.de/bauelemente/bausaetze-module/bausaetze/ https://www.pollin.de/bauelemente/bausaetze-module/bausaetze... As long as you don't connect to mains power and you don't ship a finished product, you're exempt from CE certification. So use an USB plug as your power supply and sell it as DIY kit to be assembled by the customer and you're good to go.
- pjc50 2y agoThe US and EU regulatory systems are quite different.
- okanat 2y agoThis exact blog also complained about EU regulation and selling stuff in EU. I think they basically don't know what they are doing.
- pjc50 2y agohttps://flyingcarcomputer.com/posts/strategy-for-eu-bootstrapping-hardware-startups/ https://flyingcarcomputer.com/posts/strategy-for-eu-bootstra... ? I agree about the ambiguity of CE marking. It's pretty impenetrable as a non-expert. I wonder if he's referring to Fabius the Delayer. > It even made me suspect that it is easier for a non-EU country to sell to customers in the EU than it is for an EU company to do the same. An advantage that Chinese businesses surely enjoy. 100% correct. There's way too many small parcels for customs to check them; the major nuisance is the recipient having to pay the tax themselves. > If one were to incorporate in Estonia but not sell to anyone in Estonia, or any member of the European Union for that matter, that company would theoretically be exempt from a whole cluster of legal and tax headaches. .. but why would you do that? This guy appears to be a US national, he should just register in Delaware like everyone else. The Estonian company and "E-Estonia" system is primarily useful if you do want to do business in the EU and have a presence there. If you're not in the EU and want a flag of convenience company registration, the usual places like Grand Cayman offer their services.
- buescher 2y agoYou can find statements and notices and citations and such on the FCC web site to see what happens if you get caught out. If you're interested in that kind of thing, they're interesting reading. Here is a pretty bad scenario for apparently willful unintentional radiator violations, where an ultrasonic foot bath company was at best unorganized and slow to comply with testing and labeling requirements: https://docs.fcc.gov/public/attachments/FCC-18-67A1.pdf https://docs.fcc.gov/public/attachments/FCC-18-67A1.pdf Here is a better scenario, where an LED sign manufacturer was a bit more on the ball: https://docs.fcc.gov/public/attachments/DA-22-1136A1.pdf https://docs.fcc.gov/public/attachments/DA-22-1136A1.pdf Note in both cases there is no mention that these devices emitted RF above allowed limits for unintentional radiators. These companies simply didn't test and didn't label their devices appropriately. Here's one for Asus, where they got WiFi products certified, and then changed something, probably firmware, that allowed those devices to transmit more power than allowed: https://docs.fcc.gov/public/attachments/FCC-24-69A1.pdf https://docs.fcc.gov/public/attachments/FCC-24-69A1.pdf
- cwoolfe 2y agoYes! And don't forget to somehow encrypt the data on your SD cards, or do a check-in with the cloud to activate, otherwise your customers can make copies and give away all your software for free!
- zkirill 2y agoI am opposed to DRM and would never do that.
- RecycledEle 2y agoI have rarely seen someone this happy to add friction that prevents his customers from buying his product.
- AnarchismIsCool 2y agoOk so as someone working on something vaguely similar (portable computer, slightly different market, more RF focus) I assure you this person is just rambling on a blog. Basically everything on their blog/faq ranges from inept to dangerously misleading.
- mschuster91 2y ago> Variations of the FCC exist in pretty much every developed economy. Putting a poorly tested hardware product on the market immediately puts a target on your back. Maybe you’ll get lucky, but chances are that someone somewhere will report you. And, unless you are operating entirely out of China, it will hurt. A lot. Both your company and maybe even you, personally. And that for good reason. Any bad actor on the RF spectrum can be an actual, significant and direct threat to people's lives - particularly the EMS bands as well as the rail, marine and flight safety/coordination channels are absolutely vital. Up next is stuff like GPS, radio and television where disturbances affect a lot of people, and then there's local stuff like wifi, Bluetooth, Zigbee, door openers and whatnot that only affects very few people. Unfortunately it is very, very easy to be a bad actor on the airwaves. Powerline/PLC is hated by radio amateurs for a reason, and that one is actually even licensed. The other stuff is much, much worse.
- iamleppert 2y agoIs it possible to couple compliance testing with an LLM? I smell a new business model.
- andrewstuart 2y agoThis was a missed marketing opportunity to say what the product is.
- zkirill 2y agoSubscribe to the mailing list and you'll be the first one to find out! Seriously, though, HN is not my target market. I just needed a sounding board. Although, getting to the front page did grow the subscriber count from 7 to 48 people in 24 hours.
- dublin 2y agoRegulatory certification is a shakedown racket that makes the Ticketmaster monopoly discussed a few items down look like a friendly environment. Do you wonder why all of your new electronics are made in China? One big reason is that China has its own regulatory labs (which may or may not do testing - who knows?) that are literally at least an order of magnitude cheaper than getting certification done in the US or Europe. I'm working on two client products now that I and the clients would prefer to have made here in the US, but both will be made in China because the companies literally cannot afford the rapacious cost of getting them certified here. (And China mfg is way cheaper, too - partly because of parts distribution models: It's literally cheaper to buy a finished product from China than to buy the components here to assemble the same product!)
- pedalpete 2y agoWe've been developing a wearable, which is classified as a medical device, so we've been looking at the FCC/CE/etc regulations for a while. We're using ESP32s, and are currently going through ethics approval, which, from what I understand, means we can use the device prior to sale, but maybe we've got that wrong. I can't imagine having to have each hardware iteration certified by the FCC. What struck me more about this article is the subject of marketing. For companies that are doing pre-sales, and are still in development, and likely haven't been certified yet. Isn't that considered marketing? How are other companies handling this? We're looking to run a marketing trial in a few months, and marketing is part of the recruitment process for a trial.
- negative_zero 2y agoEthics approval for a medical device is a completely different thing from EMC regulations (which is what normally people mean when talking about FCC and CE for a device). "I can't imagine having to have each hardware iteration certified by the FCC." Depending on your device and the magnitude of the changes, this might simply be the reality for you. This is why I always try to tell people that you need compliance at the table from the start or you really risk making life very difficult for yourself. Find yourself a compliance specialist or at least a hardware engineer who is familiar with the regulations. EDIT: You CAN'T just iterate ad-infinitum for free without consequence like you do for software. This thinking and approach, only works in software land. No where else. It would be ridiculous to build a house and having the builder iterate on your house over 2-3 years to finish it, no?
- buescher 2y agoYou can get an experimental license from the FCC. Clinical trials are a specific example of what that process is for: https://apps.fcc.gov/oetcf/els/help/442_License_Types.html https://apps.fcc.gov/oetcf/els/help/442_License_Types.html