The goal of medical device software development should be to select a process and architecture that ensure a safe and effective product. The methods utilized to achieve this goal differ among medical ...

The Transparency Principles emphasize the effective communication of relevant information about a MLMD to users, such as the intended use(s), device development, device performance, and method for ...

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The use of smartphones in healthcare is old news. Despite the decade-old trend, many challenges still exist with utilizing a patient’s smartphone, especially with optimizing both safety and patient ...

The Medical Device Coordination Group (“MDCG”) has issued guidance on the safe making available of medical device software (“MDSW”) apps on online platforms (MDCG 2025-4). MDCG 2025-4 outlines the ...

Late last month, India’s drug regulator came out with a draft guidance document to regulate “medical device software” — this move, the medical device industry agrees, could not have come sooner. The ...