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 Medical Devices

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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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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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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