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Getting your 510K Medical Software Ready

Blog: Pathfinder Development

Medical devices have become so indispensable to modern healthcare that practically no major diagnosis or  treatment can be done without them. According to the WHO, an estimated 1.5 million medical devices are currently available, ranging from the humble digital thermometer to the highly sophisticated MRI machine. An increasing number of these devices are being driven by software external to the device, for example, a companion mobile app.

The growing popularity of software-driven medical devices has made it necessary for manufacturers to be aware

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