April 23, 2021
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...
See BlogApril 22, 2021
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)...
See BlogJanuary 20, 2021
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...
See BlogApril 13, 2020
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...
See BlogJanuary 3, 2020
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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