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Quality Management setup and certification Clinical study Technical file / DHF creation FDA Submission (510k/DeNovo) or CE marking (via Notified Body)
by oezi 3y ago
Quality Management setup and certification
Clinical study
Technical file / DHF creation
FDA Submission (510k/DeNovo) or CE marking (via Notified Body)
- WA 3y agoDepends a lot on your product, your target market(s), number of supported languages, number of employees, and most of all: the risk class of the product. QMS can be around 15-20k Study: not necessarily needed if you do not need new evidence. Then you can write a literature review, which is A LOT cheaper TechDoc: yeah, takes time CE marking: depends a lot on the notified body. Here's a slightly outdated list and apparently, you can pay anything between 15k€ to 500k€: https://openregulatory.com/notified-bodies/ https://openregulatory.com/notified-bodies/