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Posted: May 17, 2016

Nelson Laboratories and Healthmark have Joined Forces to Offer a Surveillance Tool for Testing of Duoendoscopes

SALT LAKE CITY, UT AND FRASER, MI – May 17, 2016 – Nelson Laboratories and Healthmark Industries today announced the introduction of an Endoscope Sampling Kit for the random testing of duodenoscopes in compliance with CDC guidelines. Endoscope manufacturers, regulatory bodies and healthcare facilities are increasingly concerned about the spread of communicable diseases, including clinically relevant microorganisms, on reprocessed medical devices. Healthmark Industries and Nelson Laboratories have joined forces to create an endoscope sampling kit for the purpose of monitoring and reporting objective results from clinical scopes.

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Posted: January 17, 2017

A "Particle" of Prevention Is Worth a Pound of Cure: The Significant Benefits of Premarket & Postmarket Particulate Testing of Cardiovascular Devices

The Significant Benefits of Premarket & Postmarket Particulate Testing of Cardiovascular Devices

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Posted: December 28, 2016

2016 Year in Review

This past year was an exciting one for Nelson Laboratories! We were acquired by Sterigenics International in April. With the merger of Nelson Laboratories and Sterigenics’ SteriPro® Labs, our global facilities and expertise now allow us to continue investing in new services, equipment, and facilities. We have expanded our footprint to localize our portfolio of offerings […]

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Posted: December, 7 2016

How the new FDA guidance ‘Use of International Standard ISO 10993-1' affects you and your medical device

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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