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Chemical characterization of medical device materials has become increasingly important in the past several years as a substitute for or supplement to in vivo and in vitro biocompatibility testing.With its increase has come questions about best methods and approaches.In this presentation, you will learn about:
- The place of chemical characterization and toxicological risk assessment in biocompatibility assessment.
- General approaches to conducting chemical characterization.
- An overview of the analytical process.
- Key considerations for toxicological risk assessment.
- Current trends with various regulatory agencies.
Learning Level: The topic is considered intermediate to advanced.Although it is technical in nature, no specific training in chemistry or toxicology is required.
Upon the webcast's conclusion, you will be able to understand:
- The benefits and weaknesses of chemical characterization.
- Key aspects of the process, including what suppliers need and what to expect from them.
- The key points from a toxicological risk assessment.
Who should attend
- Senior regulatory specialists and project managers
- Regulatory scientists
- Scientists/engineers and others responsible for biocompatibility or material programs
- Managers involved in material selection.
Ted Heise, Ph.D., RAC, vice president, regulatory and clinical services, MED Institute
Theodore (Ted) Heise has 25 years of experience in regulatory affairs, and currently serves as vice president, regulatory and clinical services at MED Institute. In this capacity, Heise has responsibility for the scientific aspects of the company’s global regulatory affairs efforts, including design and analysis of clinical studies of new technologies.