Lilla Strobel on MDR, MDDTech Regulatory | Quality ConsultantSome time ago
Medical Device Innovation - The sine curve If a finance plan can look like a hockey stick, regulatory consultation shall be like the sine curve. We start from 0, the customer starts to embrace the product like I was an investor. It is brand new, unprecedented, it changes the life of the whole mankind, and sure it only uses technologies like never before, the curve reaches 1. At this point, I have to ask the customer to get back to earth and help me understand the many tasks in front of us. Here the curve starts to descend, heading back to 0. I honestly tell them what is the best solution for them, and of course the costs. Things get worse: but there are many similar products on the market with the same methods (so it is not revolutionary), and they can sell it without CE mark (they can't. But hey, at least he knows what is CE mark), maybe some mansplaining added (my lack of testicles must have an effect on my job, I guess), here comes the helpless rage, because he did not expect that it costs money, how they gonna pay it ,etc (none of my business TBH). So the curve reached -1. If the curve can get back to 0, we can consider working together. I understand that it is my responsibility to keep customers down to earth, but sometimes it's hard, really hard
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Lilla Strobel on MDR, MDDTech Regulatory | Quality ConsultantSome time ago
You successfully checked MDR but got frightened? Categories? Quality assurance? Clinicals? What the... Yes, it is quite complicated, but you shouldn't be worried! #medicaldevice #mdr

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Lilla Strobel on MDR, MDDTech Regulatory | Quality ConsultantSome time ago
IVD - the special Is your medical device meant to diagnose by checking human-derived samples? (blood, saliva, urine...etc.)Congrats! You have an IVD! You need to follow the IVDR instead the MDR. You will have different categories, than Medical devices, but all other basic principle are the same! This topic is not easy! Always consult with a professional.
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Lilla Strobel on MDR, MDDTech Regulatory | Quality ConsultantSome time ago
What my job feels like https://youtu.be/EZOx1RhMHIo
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