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FDA

September 15, 2017

Introduction to the Validation of Sterile Medical Devices: Sterilization, Packaging, Biocompatibility, Toxicology, and Reprocessing

For over a decade, Nelson Laboratories has been hosting educational seminars called The Science of Sterilization Validation. The aim of these three-day seminars has been to provide MedTech professionals the opportunity to establish or refresh their fundamental testing knowledge and,...

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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 12, 2016

Reprocessing Single-Use Devices

Some devices that are marketed and validated for single use are now being used multiple times in clinical settings. To save money and to comply with green initiatives, hospitals are moving towards using third-party reprocessed single-use devices (SUDs). However, reusing...

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July 29, 2016

Human Factor Considerations for Medical Device Manufacturers

Consideration of human factors when designing a medical device should be a high priority. It is important that concerns regarding human factors are considered during the development phase of new medical devices. For many years, this phase of the process...

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July 6, 2016

New US FDA Guidance on the Use of International Standard ISO 10993-1: Top 10 Changes

As anticipated, the United States Food and Drug Administration (US FDA) issued a new guidance document on the use of ISO 10993-1 on June 16, 2016. In one statement the FDA summarizes how they want to see biocompatibility for medical...

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