Tag Archives: testing

Biological Evaluation of Medical Devices

By Jan Peeters, Paul Malinovski
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The biological safety of a device is established for both short-term (acute) and longtime (chronic) safety risks to patients and device users. Medical device manufacturers must investigate their devices thoroughly to meet these expectations to receive approval to market their devices.

The biological safety of a device is established for both short-term (acute) and longtime (chronic) safety risks to patients and device users. Medical device manufacturers must investigate their devices thoroughly to meet these expectations to receive approval to market their devices.

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How Good is Good Enough? The Importance of Medical Device Performance Specifications

Telling the parent their child has a temperature of 38.674 °C may be an impressive engineering feat, but the last two digits have no real value and any time spent in development getting there was misspent.

Telling the parent their child has a temperature of 38.674 °C may be an impressive engineering feat, but the last two digits have no real value and any time spent in development getting there was misspent.

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MEDdesign

Controlling Costs in Medical Device Development

By Joe St. Cyr
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Dozens of factors contribute to the cost of developing a medical device and every project is different. The rigor required to meet standards in the medical industry plays a huge part, but based on my experience in medical device development, several other issues often influence a project’s bottom line.

Dozens of factors contribute to the cost of developing a medical device and every project is different. The rigor required to meet standards in the medical industry plays a huge part, but based on my experience in medical device development, several other issues often influence a project’s bottom line.

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MEDdesign

Four Ways Risk Analysis and Verification Testing Can Help Prevent Recalls

By Scott Phillips
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When two highly respected companies like Abbott and Johnson & Johnson get caught up in recalls, we are reminded that thorough verification and validation are fundamental to successful medical device development.

When two highly respected companies like Abbott and Johnson & Johnson get caught up in recalls, we are reminded that thorough verification and validation are fundamental to successful medical device development.

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