3 ms·
As someone who works in medical devices I can tell you in the medical field it's not enough to just write on a box "If you use this incorrectly and get injured,
by ChrisRR 6y ago
As someone who works in medical devices I can tell you in the medical field it's not enough to just write on a box "If you use this incorrectly and get injured, it's not our fault"
Medical products have risk assessments a mile long for every scenario the manufacture can think of, and the mitigation for being administered on the wrong patient is often "Don't sell to non ISO-13485 approved clients"
If enough people get injured because of your product, the FDA or MHRA is going to investigate you, no matter how many disclaimers you put on your products.