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PRESS

Posted: January 24, 2017

Nelson Laboratories Launches Redesigned Website

SALT LAKE CITY, UT – January 25, 2017 – Nelson Laboratories, a leading provider of testing services for Medical Device, Pharmaceutical, Tissue and life science companies today announced the launch of a new, redesigned version of its website, nelsonlabs.com. Highlights of the updated site include a cleaner and more attractive design, a more engaging user experience with enhanced search and navigation features, and clearer calls to action for new and existing clients exploring the site.

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ARTICLE

Posted: April 3, 2017

Extractable/Leachable Chemistry Testing Strategies for Medical Devices

By Matthew R Jorgensen, Ph.D., and Thor Rollins, BS, Nelson Laboratories; Allison Komiyama, Ph.D., RAC, AcKnowledge RS
Published: Medical Device Outsourcing 

It has become more prevalent and acceptable to use the results of chemistry testing to assess the overall biocompatibility of medical devices. For many devices with prolonged or permanent patient contact, chemistry followed by toxicological assessment can provide a cost and time saving alternative to in vivo tests such as chronic, sub-chronic, genetic, and carcinogenicity testing. Manufacturers preparing to submit their device for approval by the U.S. Food and Drug Administration (FDA) rely on ISO 10993 standards and FDA guidance on the application of those standards in the planning of their chemistry testing. When it comes to the details of chemistry testing, however, the ISO standards are often vague. Furthermore, the recommendations regarding the appropriate level of testing rigor can vary within FDA. The following offers a brief overview of the framework provided by ISO 10993 guidance documents for extractable/leachable (E/L) testing, as well as three testing strategies that satisfy both ISO 10993 and FDA requirements.

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BLOG

Posted: April 3, 2017

AAMI STERILIZATION STANDARDS MEETING UPDATE

By Emily Mitzel, MS On March 20-23, 2017, I attended the Association for the Advancement of Medical Instrumentation (AAMI) semi-annual Sterilization Standards Committee Meeting. These Association meetings, and the standards discussed during them, have a major impact on medical device manufacturers, testing facilities, HCF managers, and FDA.  It is important for industry experts to participate […]

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VIDEO

Posted: February 8, 2017

MDM West Tech Theater: New FDA Guidance on ISO 10993-1 and How it Affects You

In April of 2016, the FDA released their long-awaited guidance document on ISO 10993. This 65 page document provides insights and changes to how the FDA views biocompatibility. We will discuss the top 10 items in the document that will make the greatest impact; we will also discuss how this update impacts the newest draft of ISO 10993-1. Attendees will expect to learn:

  • The most current FDA trends regarding biocompatibility
  • How to add risk management into biocompatibility
  • How material/chemical characterization plays a role in biocompatibility
  • What’s on the horizon for change in biocompatibility

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