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Date(s) - 05/07/2019 - 05/09/2019
All Day

Westin Arlington Gateway


NAMSA invites you to meet with us at the Extractables and Leachables 2019 conference in Arlington, Virginia on 7-9 May. This event brings together leading experts and decision makers from across the medical device industry to share the latest updates on regulations, best practices and compliance, biocompatibility and much more.

NAMSA Education Session
May 8, 2019 | 10:00 AM EDT
Solvent Selection in Chemical Characterization of Medical Devices
Presented by Joshua Young, PhD; Senior Study Director, NAMSA

Description: With the recent release of ISO 10993-1:2018, and the highly anticipated revision to ISO 10993-18, chemical characterization testing has skyrocketed to the forefront of necessary information for toxicological evaluation of medical devices. With increased scrutiny on the necessary threshold limits needed for chemistry data, the study design for an effective extractables characterization must include careful assessment of the extraction solvents and the anticipated material interactions.

This presentation aims to explore several common methods of assessing the appropriateness of extraction solvent-polymer pairings by providing case studies which demonstrate the effectiveness of these approaches.

  • Solvent Selection
  • Polarity
  • Chemical Characterization
  • Medical Devices

Complimentary Consultations
NAMSA’s medical device development experts will be available throughout the conference for complimentary consultations. We welcome the opportunity to discuss the most efficient and cost-effective pathways to market based on your unique product development requirements. We’ll also walk you through our latest success story, which discusses the significant milestones that NAMSA achieved in partnership with Dental manufacturer, Solvay Dental 360, including information on how the organization saved $7.5M and 12 months in 510(k) development costs.

Please contact us at communications@namsa.com to schedule your consultation time! We look forward to meeting you.