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The ISO 10993 standards are used by medical device manufacturers for the evaluation of biological safety testing, and in late 2018 they were updated to adopt a more risk-based approach to biocompatibility testing.
Over four weeks this course will provide you with a baseline understanding of the key changes to ISO 10993 and what you need to include in an evaluation under the new requirements. In addition, you will be able understand biocompatibility in the context of risk management, the MDR safety requirements and from a global perspective, cemented by a series of case studies.
Suitability - Who should attend?
This course will be useful for anyone new to biocompatibility for medical devices, or who would like a refresher of this material and update their understanding of regulations, including:
- Regulatory Affairs
- Quality Assurance
- Manufacturing, development and design
- Process development
Training Course Content
- Understand the relationship between biocompatibility testing and ISO 14971
- Analyse ISO 10993-1 and its updates
- Explore material characterisation in its different forms
- Examine the MDR safety requirements in the context of biocompatibility
- Recognise the differences in the EU MDR and FDA 510(k) approaches
- Review the relevant End Points for Consideration
PTI - Pharmaceutical Training International - Training for the Pharma Industry
PTI is the global leader in professional education for the pharmaceutical industry, delivering a broad course portfolio that covers the industry spectrum: R&D, Clinical Development, Generics, Bio-pharmaceuticals, fine Chemicals, Agro-chemicals, Medical Devices, Animal Health, Manufacturing and Regulations. PTI's open courses,...
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