• 1 Post
  • 12 Comments
Joined 1 year ago
cake
Cake day: July 1st, 2023

help-circle








  • You need an incredibly robust quality management system to even achieve certification (allowing you to place on the market) when creating systems which include life support function, or functions which potentially could kill a user. All potential changes both within and outside of the manufacturers’ control MUST be assessed and constantly monitored so such issues CANNOT arise.

    No one should be able to legally place an unsafe app on the market, or legally perform changes to the app without the necessary checks and balances.

    Medical device approvals in most countries are definitely not the wild west. Although they are not perfect.





  • This is not correct for devices being sold to the EU at least. Part of the amendment to the Radio Equipment Regulation outlines the exact standards for power delivery that must be used, and that interfaces which are capable of being charged @ > 15W must “ensure that any additional charging protocol allows for the full functionality of the USB Power Delivery…”.

    For data transfer, I don’t see the point and future improvements to USB will come from industry in future.

    The only way around this is with a wireless charging protocol, but manufacturers are moving away from that it appears.