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SiMD (Software-in-a-Medical-Device) is software that is embedded in a medical device and functions as a component of that device.
On the other hand, SaMD (Software-as-a-Medical Device) is standalone software that performs medical functions without being part of any hardware.
While SiMD relies on a specific device to operate, SaMD can run on general computing platforms and is often more flexible in its applications.
Class I, II, and III medical devices vary in risk levels and regulatory requirements.
Class I devices are low-risk and need basic controls such as labeling. Examples include bandages and tongue depressors.
Class II devices have moderate risk and require additional controls like performance standards, infusion pumps are an example.
Class III devices are high-risk and need pre-market approval. These are often life-supporting devices like pacemakers.
The FDA approves medical device software through a rigorous process that evaluates its safety and effectiveness.
Initially, developers submit a pre-market notification or a pre-market approval application, depending on the device's risk classification.
The FDA reviews the software's design, clinical data, and quality assurance measures.
After successful evaluation, the FDA grants approval, allowing the software to enter the market.
Almost every medical device now runs on software to enhance precision, data analysis, and ease of use. Software allows for real-time monitoring and quick adjustments, which are crucial in medical settings.
Common examples of medical devices that rely on software include infusion pumps, ventilators, and diagnostic imaging systems like MRI and CT scanners.