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Grayscale photo of regulatory documents, stethoscope, and tablet representing regulatory challenges in software medical devices compliance.
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June 21, 2025June 21, 2025Industry Focus, Medical Devices & Healthcare

5 Regulatory Challenges in Software Medical Devices

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5 Regulatory Challenges in Software Medical Devices Software is increasingly at the core of modern medical devices. From diagnostic tools powered by AI to mobile health apps tracking vital signs, software-based medical devices are transforming healthcare delivery. But with innovation comes regulatory challenges in software-based medical devices. Manufacturers, developers, and legal teams must navigate a...

Medical device workspace with data charts, microscope, and clipboard symbolizing post-market surveillance activities in compliance and safety monitoring
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June 14, 2025June 14, 2025Industry Focus, Medical Devices & Healthcare

What Is Post-Market Surveillance (PMS)? Definition and Examples

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Post-Market Surveillance (PMS) is the ongoing process of monitoring a product’s performance, safety, and compliance after it has been released into the market. Common in the medical device and pharmaceutical sectors, PMS ensures that products continue to meet regulatory and safety standards throughout their life cycle. It includes collecting data, analyzing feedback, and responding to...