SALT LAKE CITY – Nov. 15, 2013 – Nelson Laboratories (www.nelsonlabs.com) will offer free biocompatibility 
consultations in its booth (#321) during BIOMEDevice in San Jose, CA Dec. 4-5, 2013 with expert Thor Rollins, biocompatibility specialist. Those interested in a consultation should register at [email protected].
Rollins will also present, “Selection, Testing and Validation of Medical Devices According to ISO 10993,” from 10:00 am to 12:00 pm Dec. 5. The presentation is free, but participants should register at http://www.canontradeshows.com/expo/biomed13/conf_Nelson_form.html
“During the presentation, we will discuss materials that can have an impact on test results, which specific tests to use, and how to confirm test results,” said Rollins. “For those who want to dig a little deeper, we will also be conducting free biocompatibility consultations.”
During the consultations, participants can go over any biocompatibility topic they wish with Rollins. Some suggested topics may include:
- Setting up a biocompatibility test plan
- What happens if you fail a biocompatibility test
- Materials characterization testing
- ISO updates/changes
- Materials justifications
Rollins’ presentation will cover:
ISO 10933 Test Requirements and how Materials Could Impact Biocompatibility Testing:
- An overview of the most common biocompatibility tests and what materials could impact the results
- How FDA and other regulatory agencies will interpret your results or test selection
- How the new FA Draft Guidance might impact your future testing
- How to categorize you device according to ISO 10993
Materials Characterization for Medical Devices per ISO 10993-17,18:
- The correct way to extract your device to look for extractables and leachables
- What tests to run to identify and quantify the compounds
- How to determine the potential toxicological impact of the compounds
What To Do If You Fail A Compatibility Test:
- How to confirm the result
- How to trouble shoot and ways to improve you device
- How to justify a failure
About Nelson Laboratories: Nelson Laboratories is a leading provider of full, life-cycle microbiology testing services. We are known for exceptional quality, but we look beyond the testing process and partner with you to achieve your long-term business goals. It’s what we call The Science of Success™. Learn how we can help move your products to market quickly and safely. Visit www.nelsonlabs.com.
Author: Thor Rollins | Google+
