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Can you go into a little detail on the expenses that 1m needs to cover?



Quality Management setup and certification

Clinical study

Technical file / DHF creation

FDA Submission (510k/DeNovo) or CE marking (via Notified Body)


Depends 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 Here's a slightly outdated list and apparently, you can pay anything between 15k€ to 500k€: https://openregulatory.com/notified-bodies/




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