Risk Management in Medical Device Development

A special case of risk management is in the development and marketing of medical devices. Designing, ensuring, and certifying that they are safe for human interaction be it for daily patient care, invasive or non-invasive, diagnostic procedures, or scientific research. The risks may extend to other patients, operators, external equipment or the environment on a micro or macro scale.

The challenges, however, are that risks can present themselves at any point in the lifecycle of the product. Capturing and assessing all risks is both difficult, time-consuming, and error-prone because many medical device manufacturers today are dependent on traditional paper-based risk management processes.

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