AssurX, Inc.

Product Quality & FDA Inspectors Demand Strong CAPA Programs
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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Creganna-Tactx Medical

Metal Shafts: Designs to meet the Required Performance
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 extended
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Electrolizing Inc.

Pultrusion Die Coating
Pultrusion dies chrome plated to increase life span and feed rates.
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Full Spectrum Software

How to Rescue a Hopelessly Stalled Software Project
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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LaserStar Technologies

Fiber Laser Micro-Welding Applicatons
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-effective al
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Raven Labs

Biological Indicators D-value and Population Verification/Assessment
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 manufacturi
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Raven Labs

Monitoring BioWaste Bags with Biological Indicators
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 a var
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TM Electronics, Inc.

Seal Strength and Package Integrity: The Basics of Medical Package Testing
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 handl
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