When it comes to adopting medical technologies, healthcare has acted swiftly and decisively. But when it comes to adopting technologies to improve their own business operations, hospitals and other medical organizations have been rather slow. This is understandable in an environment where money is tight and patient care is critical, but it's also slowed down the advancement of medical software development.
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Any software used to enable a medical device for use on human patients in the United States is subject to FDA medical software compliance regulations.