One of the advantages of being in a regulated industry is the technological barrier to entry. If you don’t understand how to design to the regulations and get the approvals, you can’t play!
Most regulations are reasonable and help you keep your customer safe. This is particularly true in the medical industry, where every country has rules that must be met before you can even market your product.
This means that from the first time you discuss your ideas, the regulations should be considered.
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