Readit NewsOnly if a wronged party has the resources (time, money, political capital) to pursue it.
Which is but one reason why it is deeply silly to rely on it to make a society go.
Only if a wronged party has the resources (time, money, political capital) to pursue it.
Which is but one reason why it is deeply silly to rely on it to make a society go.
Regulation is by nature slow and highly susceptible to corruption or stagnation. Whereas the courts, as onerous as they may be, essentially achieve the same thing through liability but it is more dynamic, more responsive, and more likely to error correct than the former.
That's why we have regulation: to establish the minimum standards.
Simple medical devices like wheelchairs (Class I or Class II) are also not super over-regulated, you don't need to do clinical trials to certify them. All-in-all it'll cost you around $10m, which is not at all a moat.
When looking at a patent check the "Claims" section. An infringing device would have to perform those steps in the order provided for the patent holder to have a claim.
Disclaimer: I am not a lawyer, but I've had a lot of dealing with patents.
I am an electronics / PCB hobbyist and I can't for the life of me figure out how they came to such a weird conclusion. What does this even mean?
Larger components will have more surface area at the joint and should be stronger than a smaller component
> On the other hand, the soldering material used to attach these resistors is prone to forming bubbles and breaking easily, according to Häfele.
Never heard of solder doing this - it seems more likely to me that the solder wasn't reflowed properly in manufacturing.
What's more is that the component pictured is a capacitor.
The only conclusion I can draw here is that the guy has no clue what he's talking about
I have a hard time accepting that because there is not a lot of heat on that line nor is there a lot of physical stress, like constant vibration on SSDs.
If I understand you correctly, you're basically saying why use a bank versus something else? My answer would be because for vast majority of retail bankers it doesn't matter. Same reason many would use Gmail vs self-host. They want to put their money somewhere and ensure that it will be there when they need it. As a society we have a framework around that and we provide deposit insurance and we call the orgs who take your deposit, give you an IOU (in the form of an account balance) then lend a fraction of it to others a bank.
For significantly larger sums no I don't think it makes sense to use a bank and most large corps have a treasury that specifically deals with that.
- approvals for version N + 1 are basically skipped, as is safety testing
- manufacturers get a liability shield
- for many classes of devices, ladder pulling implies that no one will ever get another v1 approved. (The current rules for that are impossible to meet, but the incumbent company is grandfathered in under the old rules).
The device still has to go through testing, validation and verification. It is a very detailed process and follows IEC spec. The device also needs IEC 60601 testing by a third party lab. In this case at least 60601-2-24.
The 510(k) means it is not doing something new therapeutically therefore it doesn't need to go through PMA process which so much longer and more complex. In this instance they're saying a pump that uses electronics to monitor and deliver glucose already exists. Our device does the same thing therapeutically but we do it differently and here is all out docs showing the device is safe.
If they came up with a magical patch that used quantum chemtrail energy to align the shakras and thereby affect the patient's insulin levels, then they would need to go through PMA and show the therapy is safe and works in small clinical trials followed by larger trials before they can make a device that can be marketed.