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Date(s) - 03/18/2019 - 03/20/2019
All Day

Tokyo Big Sight


NAMSA invites you to meet with us at MedTec Japan in Tokyo, Japan on 18-20 March. This conference  will concentrate on educating and informing participants on key regulatory and process issues essential to the strategic success of any medical device manufacturing business.

Special NAMSA Workshop | 13:00 – 13:30 | 20 March
Biological Safety Evaluation for Medical Devices Compliant with the New ISO 10993-1
(Presented by: Chikako Kitayama, Medical Research Scientist, NAMSA)

Since 2009, the emphasis on a risk management process and characterization of materials continues to shift the biological safety paradigm. In today’s world, there is continued interest in how an evaluation is conducted long before any biological tests are performed. In addition, with the release of ISO 10993-1:2018 in August 2018, there is a continued focus in biological safety planning and implementation processes, as well as the characterization of materials. Once again, medical device manufacturers are being asked to go beyond the simple process of identifying a set list of biocompatibility tests when evaluating a device’s biological safety. Join us for this session to learn how manufacturers can efficaciously prepare for implementation of these new requirements.

Exhibit Booth #813 | 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; please stop by Booth #813 or schedule your consultation by emailing us at communications@namsa.com.