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Biocompatibility of Medical Devices Two Day Certification Course
September 25, 2017 - September 26, 2017
Practice how to execute your plan from development to completion, and how to schedule and document the implementation of your biocompatibility plan in this certification course presented by NAMSA
- Understand and apply ISO 10993-1 and the FDA Guidance on its use.
- Discover how to use Materials Characterization and how it applies to biological safety.
- Learn about ISO 14971 and how – in combination with ISO 10993-1 – it can be used as a tool for hazard identification.
- Learn how to identify when tests are required and not required based on testing goals and needs.
- Discover how to develop a testing program that can help you successfully meet regulatory requirements and commercialization objectives.
- Gain a deeper knowledge regarding the principles of toxicology, FDA consensus standards and Good Laboratory Practices (GLP).