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August 30, 2010
Here's the truth. If an FDA inspector comes to your facility, he or she will want to see how you have configured your Corrective and Preventive Action (CAPA) program. Bet on it.…
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March 31, 2010
When designing shafts for minimally invasive devices such as catheters and guidewires, features that improve one area of performance may hinder performance in another area.This article describes how the traditional limits of metal shafts can be exten…
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March 31, 2010
Conference paper: Benchmarking the performance of various materials for catheter and specialty needle applications. Three alternative materials to 304SS are examined and compared using a range of mechanical tests and experimental trials.…
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March 31, 2010
Prototyping early in the design cycle can significantly reduce the product development lifecycle, facilitate a better overall design and reduce the risk of failure. Prototyping options for delivery devices are presented and discussed.…
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March 31, 2010
Bench-top testing of a typical catheter is described here to show how early prototype evaluation can decrease product development time. Trackability and pushability are assessed and compared using some novel laboratory tests, which can be applied to…
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January 8, 2010
A large number of end-users of Biological Indicators (BIs) are sending the BIs out to 3rd party laboratories for verification of the D-value and/or population of the BI prior to acceptance for use. Having worked within the biological indicator manufa…
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January 8, 2010
It has been noted that a fairly large number of facilities use spore strips as their
Biological Indicator (BI) for the monitoring of biowaste bags to be steam sterilized.
These waste bags include regulated medical waste (RMW), biological waste and…
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March 24, 2008
Full Spectrum Software is making available a new report to help medical device companies get stalled software projects back on track.…
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February 29, 2008
LaserStar Technologies FiberStar laser welding workstation features a fiber laser engine. This addition to the LaserStar product range is in recognition of the growing acceptance of fiber lasers for materials processing applications as a cost-effecti…
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March 20, 2007
The objective of package testing for medical packages is twofold: first, to ensure the integrity of the sealed package, and second, to assure that no weaknesses in the sealed areas of the package permit leaks to develop during sterilization, normal…
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