What is Software as a Medical Device?

By Marion Lepmets, CEO of SoftComply* & Tom Stamp, CEO of Blue Curve** If it looks like a duck, swims like a duck, and quacks like a duck, then it’s probably a duck… or a medical device! Medical devices can be purely hardware based (eg stethoscopes), be composed of hardware and software (eg patient monitor) […]

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An Overview of Medical Device Software Regulations – International Standards and FDA Guidance Documents

Medical Device Software Safety Safety is the central concern for medical device software development. Development of safe systems is rigorously supported by various regulatory requirements focusing on development process compliance. In other words, a strong emphasis is placed on regulatory oversight and device approval before market release to ensure proper verification and validation of these […]

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