Tag Archives: patient safety

Build the Right Medical Device Recall Team

By Maria Fontanazza

From ensuring patient safety to protecting a company’s reputation, the product recall process starts with putting together the right team of qualified individuals.

From ensuring patient safety to protecting a company’s reputation, the product recall process starts with putting together the right team of qualified individuals.

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Building the Clinical Risk Perspective into Medical Device Manufacturing

By Thomas Maeder

The evaluation and management of risk throughout the product life cycle is the single most important concept in the regulation of medical devices. Yet it is difficult to define precisely what “risk” means or how to assess it in an industry where some 115,000 devices are produced by thousands of manufacturers, employing a dizzying array of technologies destined for use in varying health settings for every imaginable indication. So who determines the risk, and where do problems typically arise?

The evaluation and management of risk throughout the product life cycle is the single most important concept in the regulation of medical devices. Yet it is difficult to define precisely what “risk” means or how to assess it in an industry where some 115,000 devices are produced by thousands of manufacturers, employing a dizzying array of technologies destined for use in varying health settings for every imaginable indication. So who determines the risk, and where do problems typically arise?

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