Regulatory Approach on Classification of Software as Medical Devices

Technological advancement has created novel ways of diagnosing illnesses and treating them. Tools like 3D printing have brought down prices for prosthetics, implants, and surgical training. On the other hand, machine learning and artificial intelligence have revolutionized diagnostic methods to make them cheaper and more accurate.

Software-based diagnostic equipment is at least as efficient as the best and most qualified specialists and is improving itself continuously. It is expected to outperform the best of human beings both in patient care and in diagnosis and treatment.

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