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ISO

June 7, 2022

A Haystack with No Needle: Is an Extractables Study Appropriate for Limited-Contact Devices?

With the update to ISO 10993-18, is an extractables study required for all medical devices regardless of contact type and duration of contact? In this article, Helin Räägel, Matthew R Jorgensen, and Thor Rollins from Nelson Labs share insights on...

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November 18, 2021

Four Important Things to Know About Particulate Testing and Medical Devices

Particulate testing is required for medical devices to ensure patient safety, but there isn’t a lot of guidance available.  Here are four important things you need to know about particulate testing on medical devices. First, while there are some device-specific...

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December 15, 2017

Martell Winters is Convener for ISO WG16

It was recently announced that Martell Winters, B.S., RM/SM(NRCM) was appointed and approved as convenor for a three-year term of a new ISO working group, WG16, on vaporized hydrogen peroxide sterilization. The new working group is tasked with developing a new...

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September 6, 2017

Three-Day Webinar Series: Medical Device and Pharmaceutical Testing Regulatory Updates, Trends, and Anticipated Changes

Learn from the industry-leading experts at Nelson Laboratories in the three-day webinar series Medical Device and Pharmaceutical Testing Regulatory Updates, Trends, and Anticipated Changes including FDA, ISO, USP, and MDRs. The experts at Nelson Labs are teaming with MD+DI to...

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October 28, 2014

ISO 16775: The Medical Device Packaging Professional’s Latest “Must Have”

If you are involved in the packaging of medical devices, your primary standards reference has probably been the International Organization for Standardization (ISO) 11607 publication for packaging design and validation. However, this standard was lacking much of the detail and...

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