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sdl3 started the topic Expense of Regulations in the forum Risk Analysis for Medical Devices 8 years, 4 months ago
Hi,
I wanted to talk about something that come up occasionally at work. When I work on projects, I need to reference standards for various controls in the medical device market, like ISO, FDA, USP, AATB, ASTM, and others. However, I have noticed that in order to use them, the company has to purchase them and they are not cheap. You also don’t get a full preview of the regulation so it isn’t perfectly clear whether or not they are the correct standard for your application.
Why do you think these regulations cost money? Does it make sense that companies (especially start ups) should pay for viewing and using regulations? Is there a better way to allow everyone to be compliant without so much expense?
Savannah