Toronto, Canada (PRWEB) June 18, 2014
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.
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