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.
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
Posted: January 21, 2017
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