3 ms·
One important thing which isn't mentioned in the article is that you need at least 1m EUR/USD to become a company with a medical device. So you better have a pl
by oezi 3y ago
One important thing which isn't mentioned in the article is that you need at least 1m EUR/USD to become a company with a medical device. So you better have a plan to to raise such money, spend and recoup it with revenues.
- Jimmc414 3y agoCan you go into a little detail on the expenses that 1m needs to cover?
- oezi 3y agoQuality 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 Here's a slightly outdated list and apparently, you can pay anything between 15k€ to 500k€: https://openregulatory.com/notified-bodies/ https://openregulatory.com/notified-bodies/
- nradov 3y agoFor most hardware devices that's correct. But software as an FDA Class I medical device can be done cheaper than that. Under US regulations, pure software with no hardware component can be considered a "medical device" depending on functionality.
- pintxo 3y agoIn my past company we looked at EU MDR class 2a certification, we established it would cost around 100k€/a to get and maintain all necessary certifications. Essentially hiring a full-time resource to do all documentation, plus costs due to slower work cycles, plus certification reviews, plus external consulting as needed. Ultimately we closed shop before we starting going down that route, so I cannot tell if that number was correct.