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Medical technology software forms an important part
of the medical device industry and recent changes
to the regulatory landscape across regions, with
respect to the classification and approval process of
medical devices, is bound to affect the medical technology
industry. While the FDA approval process requires that the
device be proved efficacious in comparison to a control device or be substantially equivalent to a predicate device, the EU
approval process is based on the intended function of a
medical device. Several recent high-profile device failures
have resulted in the regulators in both regions calling for
stringent controls over the approval process of medical
devices.

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