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Validating Software as a Medical Device (SaMD)
Software in the healthcare industry has come a long way over the past 20 years. Medical device companies, like most life sciences companies, were a bit hesitant to incorporate software and automation into their processes. However, software is now ubiquitous to varying degrees in every medical device company.
For years, insulin pumps and pacemakers relied on physical devices with embedded software to run properly. Now, users can control them via Bluetooth. Even cochlear implants can connect to smart phones directly via Bluetooth.
Now we’ve reached the point where software is the medical device. While that seemed like sci-fi 20 years ago, advances in artificial intelligence (AI) have paved the way for software as a medical device (SaMD).
Read the full article HERE
