![]() You can choose Windows, Mac OS, Linux, MS-DOS, IRIS…. To work on your laptop you need an Operating System (OS). I’ll make an analogy to your computer so you have a better understanding. Let’s say, it’s the ISO for medical devices. ISO 13485 is one type of Quality Management System. If it exists, put it on the comments)įirst of all, you need to know that you don’t need specifically “ISO 13485” but you need a Quality Management System. (I don’t know if this is really an IKEA reference but I am sure that my invented name is close to one of their product. ![]() It’s like if you go to IKEA and someone tells you that you need to find the reference “Ikdabup”. Technically there is a problem because you don’t know what is ISO 13485. Īnd one of this lot of thing is ISO 13485 new version. But when you ask how you should do that, people tell you that you need “ ISO 13485 ” ![]() Ok, let’s say that you have a good idea for a medical device.
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