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Current Regulatory Expectations Affecting the Validation of Reusable Medical Devices is Subject of Dec. 4th Seminar in Boston
Date:11/12/2013

AGAWAM, Mass., Nov. 12, 2013 /PRNewswire/ -- A half-day seminar focusing on current regulatory expectations in the validation of reusable medical devices is the subject of a seminar set for Dec. 4th in Waltham, Mass., near Boston.

The validation of reusable medical devices is at the forefront of the FDA's efforts to ensure patient safety. Requirements for the cleaning, disinfection, and sterilization of reusable devices are constantly changing. The situation challenges manufacturers both in terms of deciding which testing methods to employ as well as the planning of end points.

The seminar will provide attendees with the knowledge they need to know about current regulatory expectations so they may better prepare their submissions for FDA acceptance — and avoid the time-consuming and costly requirements of additional testing.

Seminar topics will include:

  • Discussion of the FDA's draft guidance for industry and FDA staff, "Processing/ Preprocessing Medical Devices in Healthcare Settings"
  • Methods used for the cleaning and validation of reusable devices
  • Methods for the disinfection of reusable devices
  • Methods for the sterilization of reusable devices
  • Testing requirements
  • Detailed discussion of endpoints for cleaning validation

The seminar will be presented by Microtest Laboratories, a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries, on Wednesday, Dec. 4, 2013, from 9 a.m. to 1 p.m. at the Conference Center at Waltham Woods in Waltham, Mass., just outside Boston. Registration is at 9 a.m. A continental breakfast, break refreshments, and a luncheon are included.

To register, visit http://goo.gl/DvaECn or contact Julie Adamski 1-800-631-1680, ext. 192, or jadamski@microtestlabs.com. Advance registration is $149.

About Microtest Laboratories    
Microtest Laboratories is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, USA, the company provides expertise and flexible processes that enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680. Follow Microtest Laboratories on Facebook at http://facebook.com/MicrotestLaboratories, on LinkedIn at http://goo.gl/H8ZLnM or on Twitter @MicrotestLabs.

Available Topic Expert(s): For information on the listed expert(s), click appropriate link.
Steve Richter, Ph.D.    
https://profnet.prnewswire.com/Subscriber/ExpertProfile.aspx?ei=42622


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