Colorants in Devices: Integrated Strategies Toward Regulatory Approval, New Webinar July 8th Hosted by Xtalks

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During this live webinar, Mark Thomson, North America Sales and Marketing Manager at Arazy Group Consultants Inc., will talk about effective go-to-market strategies and Arazy Group’s cloud-based regulatory management system LICENSALE.COM™, which streamlines, simplifies, and expedites medical device registration in 100 countries worldwide. Moving from a broader discussion on regulatory strategies to a specific challenge faced by medical device manufacturers, John Iannone, Program Manager for Extractables/Leachables & Special Studies at Toxikon Corporation, will discuss the regulation of colorants in medical devices and testing strategies to meet requirements for a successful regulatory submission.

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A challenge common to all medical device manufacturers, regardless of their products’ level of risk, indications of use, or technical specifications, is pre-market approval.

An integrated strategy towards regulatory approval is the most critical step for the future of any medical device. Leading regulatory consultancy Arazy Group and one of the world’s premier accredited research and testing facilities, Toxikon Corporation, have established a successful cooperation to aid medical device manufacturers to comply with safety requirements and achieve regulatory approval in global markets.

Key topics include:

  • Effective go-to-market strategies and new ways to streamline and expedite global medical device registration
  • Colorants in medical devices: The spectrum of current regulatory expectations
  • Biocompatibility & ISO 10993
  • Extractables and Leachables/Chemical Characterization of Materials
  • When & How to Pool Samples
  • FDA approved color additives 21 CFR, 73, 74, 81 & 82
  • Toxicology Risk Assessments

For more information or to register for this webinar, visit: Colorants in Devices: Integrated Strategies Toward Regulatory Approval.

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global Life Sciences community. Every year, thousands of industry practitioners (from pharmaceutical & biotech companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

To learn more about Xtalks, visit
For information about hosting a webinar, visit

Michelle Tran
Tel: +1 (416) 977-6555 ext 352
Email: mtran(at)xtalks(dot)com

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