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Author: Wendy Mach





April 23, 2021

Learn about Nelson labs Medical Packaging Validation 101 Webinar (Podcast)

On this episode of SPOT radio, Charlie Webb speaks with Wendy Mach with Nelson Labs about their Packaging Validation 101 Webinar. This online event will cover topics such as: determining the appropriate sample size for testing, writing the validation protocol, developing...

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April 22, 2021

Custom Packaging Typically Required for Orthopedic Devices

It’s not over just yet. Eclipsed for the past year by COVID-19, medtech’s long-simmering ethylene oxide (EO) controversy could soon flare up (again) as the industry grapples with alternative sterilization methods for its products. The U.S. Environmental Protection Agency (EPA)...

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January 20, 2021

Disinfection Validation: How to Classify and Validate Your Medical Device Disinfection Process

Medical device reprocessing, and the scientific validation of reprocessing instructions, are critical steps to ensuring devices are safe and effective for patient use. The pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus responsible for COVID-19, as...

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April 13, 2020

HealthPack 2020 Conference Summary

Each year medical device packagers, engineers, directors, managers and quality teams meet to discuss upcoming industry trends, regulatory updates, and issues associated with common packaging ordeals and this year’s event in Charlotte, North Carolina was no exception. Due to current...

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January 3, 2020

It’s time for your Annual Radiation Sterilization Assessment

With the beginning of the New Year comes the responsibility of reviewing your present radiation sterilization process.  One of the most commonly overlooked parts of this assessment is the annual review of product family groupings.  After four (4) quarters of...

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