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Software as a Medical Device is being Validated

Over the last two decades, Software in the healthcare business has come a long way. Medical device businesses, like the rest of the life sciences industry, were cautious to integrate and automation into their operations. Software, on the other hand, is now present in every medical device company to varied degrees. Insulin pumps and pacemakers have been reliant on physical devices with embedded Software for years.

Users can now control them through Bluetooth. Bluetooth allows even cochlear implants to link straight to smartphones. We’ve arrived at a point where has replaced the medical instrument. While it may have appeared science fiction 20 years ago, advancements in artificial intelligence (AI) have cleared the door for Software to be used as a medical device (SaMD). Validating Software correctly is critical for assuring compliance, patient safety, and product quality.

SaMD is no different. It’s still new enough that government authorities are figuring out how to control it. The US Food and Drug Administration (FDA) produced a “Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan” at the start of the year, but it lacks validation.

In 2002, the FDA issued its most recent final advice on computer Software validation (CSV). The FDA’s Center for Devices and Radiological Health (CDRH) has decided that an upgrade is needed and has shifted the conversation to computer Software assurance during the last few years (CSA). CSA emphasises critical thinking and proper risk assessment, and is intended to relieve life sciences organisations of the load that traditional CSV imposes. While the final advice has not yet been released, FDA has provided enough information on the ideas involved to create a clear picture of what it will contain. CDRH regulates medical equipment, hence their approach toward validation will most likely be carried over to SaMD.

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