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  • hm243 replied to the topic Expense of Regulations in the forum Risk Analysis for Medical Devices 8 years, 2 months ago

    The regulations are highly important in ensuring that the product follows the correct standards and is safe to use in the medical device market. It does seem a little unfair that the company has to pay for the regulations, but don’t even get the full document, only a viewing. Sometimes they do not need document but they already paid for it and it seems like waste. The preview of the document should be given for free or rented, as someone else said, and if it is the necessary document then they should pay for it. The full document should be paid for to account for the work that went into creating the documents and continuously updating them as the regulations change. As difficult as it may be for startups to afford the documents, it will make them stay up to date with the regulations and create a good image for themselves.