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  • andria93 replied to the topic FDA about upgraded device in the forum Introduction to Project Management 7 years, 4 months ago

    I think it depends on what type of upgrade you are looking for. From my work experience with Innodisk which is a company manufacture SSD and DRAM. One of the vertical we focus on is a medical market, and one of the requirement to upgrade a medical device with our SSD is required to go through FDA approval. Even it’s not going to affect the device performance. it is just a data storage but since these work dependant on different FW based on the controllers. different systems react differently. So, after speccing in the project and run testing they apply for FDA approval. Also, we have our own series of medical vertical.