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Nelson Laboratories to Present Latest FDA Trends at MEDevice Forum San Diego
Date:9/5/2012

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.

(Logo: http://photos.prnewswire.com/prnh/20120727/LA47745LOGO)

"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
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