Articles Related to Sterilization and Decontamination
McCarthy Tetrault AI-enabled medical devices are transforming healthcare by improving diagnostics and treatment, but they also challenge existing regulatory frameworks, prompting Health Canada and the FDA to develop risk-based, lifecycle-focused approval pathways that emphasize transparency, bias mitigation, and adaptive oversight through tools like the Predetermined Change Control Plan.
Visit https://www.mccarthy.ca/en/insights/blogs/techlex/ai-enabled-medical-devices-transformation-and-regulation to view the full article online.
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