SALT LAKE CITY, Sept. 5, 2012 /PRNewswire/ -- Nelson Laboratories' (www.nelsonlabs.com) biocompatibility specialist Thor Rollins will present the latest FDA trends impacting implantable devices to help medical device manufacturers make the best product testing decisions at MEDevice Forum San Diego, Sept. 19-20 at the San Diego Convention Center.
"There are new tests being considered according to the ISO 10993 update that medical device manufacturers need to be prepared for," said Rollins. "Manufacturers that attend the Nelson Laboratories presentations will learn the purpose behind the updates. Although the new standards are not official, the information gives you insight on the current thinking from regulatory agencies."
Watch a 3-minute video on the ISO 10993 update.
Rollins will be at the Second Annual Design of Implantable Device Conference within MEDevice Forum San Diego to present Establishing Implantable Devices as a Distinctive Subcategory with Specific Regulatory, Reliability and Test Concerns According to ISO 10993 on Wednesday, Sept. 19 at 1:30 p.m. The presentation will teach manufacturers how to:
- Select tests for interactions with blood
- Evaluate tests for genotoxicity, carcinogenicity and reproductive toxicity, specifically, hemocompatibility and when to perform the direct and indirect methods.
- Understand the complement activation test
- Examine the issues and solutions around in vivo and in vitro test methods
Rollins will also present FDA Trends Impacting Hemocompatibility & Genotoxicity, Including an ISO 10993 Update at the Innovation Briefs Theater in booth #537 on Wednesday, Sept. 19 at 12:00 p.m.
Conference attendees that would like to speak to a Nelson Laboratories representative may stop by booth #302 to ask any questions about these presentations or other medical device testing topics.
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. It's transparency in the testing process. It's approachable experts that guide you through ever-changing compliance requirements. It's helping you mitigate risk, be first to market, and succeed with your customers. Learn more at www.nelsonlabs.com.
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SOURCE Nelson Laboratories