Risk Management in Medical Device Development

Risk Management in Medical Device Development

In a perfect world, all risk would be avoided with careful assessment and mitigation. In reality, risk management is not a one-time event – it continues throughout the product lifecycle. Why? Requirements change with shifting market expectations, company priorities, acquisitions, black swan events, and customer feedback. Read this whitepaper to learn how your risk management documentation must reflect these changes, and in the case of an audit, be able to report why the adjustments occurred.

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Risk Management in Medical Device Development

In a perfect world, all risk would be avoided with careful assessment and mitigation. In reality, risk management is not a one-time event – it continues throughout the product lifecycle. Why? Requirements change with shifting market expectations, company priorities, acquisitions, black swan events, and customer feedback. Read this whitepaper to learn how your risk management documentation must reflect these changes, and in the case of an audit, be able to report why the adjustments occurred.

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