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Colorants in Devices: Integrated Strategies Toward Regulatory Approval

Click here to register for free and to view the entire webinar: http://xtalks.com/Colorants-Medical-D... Speakers: 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