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July 8, 2014

Colorants in Devices: Integrated Strategies Toward Regulatory Approval

Speakers for this Event:
  • Mark Thomson, MBA, NA Sales & Marketing Manager, Arazy Group Consultants Inc.
  • John Iannone, Program Manager – Extractables/Leachables & Special Studies, Toxikon Corporation
  • 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.

    In this webinar Mark Thomson, will talk about effective go-to-market strategies and how medical device registration can be streamlined, simplified, and expedited through Arazy Group’s cloud-based regulatory management system LICENSALE.COM™ in up to 100 countries worldwide.

    Moving from a broader discussion on regulatory strategies to a specific challenge faced by medical device manufacturers, John Iannone from Toxikon will discuss the regulation of colorants in medical devices and testing strategies to meet requirements for a successful regulatory submission.

    Key topics:

    1. Effective go-to-market strategies and new ways to streamline and expedite global medical device registration

    2. 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


    Senior level executives involved in regulatory affairs for medical device companies, including those from manufacturing services providers, consulting companies, financial/investment companies and government.

    Relevant job functions include:

    • Engineering (Biomedical, Design, Manufacturing/Production, Packaging, Process, Project, Quality, R&D)
    • Manufacturing (Packaging, Process)
    • Project Management
    • Research & Development
    • Regulatory / Compliance / Quality Assurance
    • Sales / Business Development / Marketing
    • Purchasing

    The session will also benefit pharmaceutical, biotechnology and dental product manufacturers. 


    Mark Thomson, MBA, NA Sales & Marketing Manager, Arazy Group Consultants Inc.

    Mark is a business consultant and sales & marketing expert with an extensive record of achievement within the global medical technology and healthcare services industry. Since 2013, Mark has been acting as North American Sales & Marketing Manager for Arazy Group Consultants Inc., helping medical and IVD device manufacturers around the world to successfully launch their products in multiple markets through Arazy Group’s flagship service LICENSALE.COM™.

    John Iannone, Program Manager – Extractables/Leachables & Special Studies, Toxikon Corporation

    Since joining Toxikon in 2004, John has assisted several drug and medical device developers with the development of product safety testing strategies. His areas of expertise include biocompatibility testing of combination devices, material characterization, and study design for custom microbiological and extractable/leachable studies. His responsibilities focus on providing technical support in client interface regarding unique testing requirements and facilitating the attainment of sound technical risk assessments of medical devices.


    Arazy Group Consultants Inc. is a global, multifaceted regulatory affairs firm that provides all types of medical device manufacturers with client-specific solutions throughout the product life cycle – from early development to post-market activities. With over 19 years of expertise, our experienced consultants are responsible for the successful registration of thousands of medical devices in 100 countries worldwide. Arazy Group is based in Vancouver, British Columbia, Canada. Our flagship product, LICENSALE.COM™, is our new, simple solution for registering medical devices globally.

    Toxikon Corporation is a preclinical contract research organization. We contract and partner with biotech, pharmaceutical and medical device industries to deliver exceptional product development services from concept to final product.

    For information about the recorded archive for this event contact Xtalks at (416) 977-6555 ext 371, or email register@xtalks.com


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