Lilla Strobel on MDR, MDDTech Regulatory | Quality ConsultantSome time ago
Regulatory vs. Marketing When you have a product which falls under strict regulations you want to be extra careful with marketing. You can't say things your device isn't certified for. Due to the many changes in regulations, authorities pay attention to these details, they can check your website and any press release about your product and compare it to your accepted labeling. So be careful! Always check the regulation, and don't state anything about your product. You're maybe correct, but every product shall be used according to their labeling. Labeling has strict rules, and it shall contain all the information about your product.
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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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