Nelson Laboratories’ (www.nelsonlabs.com) scientists will highlight testing processes and regulatory expectations to medical device manufacturers attending the Medical Design and Manufacturing East Show, June 7-9, 2011 at the Nelson Labs exhibit booth in the Jacob K. Javits Convention Center in New York City. Attending manufacturers will learn how to navigate the testing process, be more prepared for submissions to the FDA and learn fast, cost effective methods of sterilization.

-Nelson Labs to present testing processes and methods-

 

SALT LAKE CITY – June 7, 2011– Nelson Laboratories’ (www.nelsonlabs.com) scientists will highlight testing processes and regulatory expectations to medical device manufacturers attending the Medical Design and Manufacturing East Show, June 7-9, 2011 at the Nelson Labs exhibit booth in the Jacob K. Javits Convention Center in New York City. Attending manufacturers will learn how to navigate the testing process, be more prepared for submissions to the Food and Drug Administration (FDA) and learn fast, cost effective methods of sterilization.

 

Nelson Labs will conduct the 15-minute presentations at MD&M East exhibit booth #551. The presentations include:

 

The Big Three: Cytotoxicity, Sensitization and Irritation – presented by Thor Rollins

June 7 at 12:30 p.m., June 8at 10:30 a.m. and 2:30 p.m., June 9at 12:30 p.m.

  • Medical device manufacturers will learn the ins-and-outs of the big three tests that most every device must perform before they can be submitted to the FDA.

 

Ethylene Oxide Sterilization Validations– presented by Thor Rollins

June 7 at 10:30 a.m. and 2:30 p.m., June 8at 12:30 p.m., June 9at 10:30 a.m. and 2:30 p.m.

  • The medical device community will understand the appropriate ways to develop, optimize, and validate an ethylene oxide sterilization process.

 

Particulates: Their Role in the Medical Device Industry – presented by Tonya Morris

June 7at 11:30 a.m. and 3:30 p.m., June 8 at 1:30 p.m., June 9 at 11:30 a.m.

  • The FDA’s expectations on particulate testing, monitoring and reduction are becoming more stringent. This presentation will provide information on particulate testing methods and validation techniques.

 

Contact Lens Testing – presented by Tonya Morris

June 7at 1:30 p.m., June 8 at 11:30 a.m. and 3:30 p.m., June 9 at1:30 p.m.

  • Eye contact solution makers will learn how they should provide stand-alone (kill time) testing with stability samples to ensure the efficacy claim of the contact solutions for the FDA.

 

About Nelson Laboratories

Based in Salt Lake City, Nelson Laboratories believes in The Science of Success™. It’s looking beyond test results and partnering with sponsors to achieve long-term business goals. It’s approachable experts that guide you through ever-changing compliance requirements. It helps mitigate risk, be first to market, and succeed with customers. Learn more at www.nelsonlabs.com.



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