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Author: Alexa Tatarian





March 10, 2017

Single Use & Newly Manufactured Device Cleaning Validations

Performing a cleaning validation during the initial phase of a device’s lifecycle aids manufacturers in complying with current good manufacturing practices (CGMP) and quality system (QS) regulation as set forth by FDA for medical device manufacturers. The data gathered during...

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April 28, 2016

3D Printed Devices and Biocompatibility: Post-Printing and Finishing

In the previous two posts, the biocompatibility of 3D printed devices was discussed with consideration for the possible compounds added to the raw materials for workability and the polymer precursors and byproducts associated with photopolymerized structures. In both of these...

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March 18, 2014

Is Your New Device Clean? Learn More at BIOMEDevice Boston

Nelson Laboratories will be exhibiting at the BIOMEDevice Boston show, March 26-27, 2014, at the Boston Convention & Exhibition Center in booth #528. Presentation: Process Validations for Newly Manufactured Devices – Is Your New Device Clean? During the two-day conference...

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February 7, 2014

What You’ll Learn at the MD&M West Nelson Laboratories Classroom on Process Validations for Newly Manufactured Devices- Is Your New Device Clean?

Agenda: Alexa Tatarian will present on measuring the cleanliness (not sterility) of newly manufactured medical devices at the 2014 MD&M West Conference. Alexa is a Study Director at Nelson Laboratories in Salt Lake City, Utah. Her presentation will include: Industry...

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January 10, 2013

Material Characterization/Extractable Leachable Testing Services May Lower Cost and Time Commitment

Nelson Laboratories recently began providing Material Characterization with Extractable and Leachable testing services to help medical device manufacturers demonstrate that their products are safe and comply with government regulations.  This testing can provide a significant reduction of cost and time...

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