ISO 10993-1 Biological Evaluation of Medical Devices
Designed for medical device engineers, toxicologists, regulatory professionals, and quality staff who need to apply ISO 10993-1 within a risk management process. By the end, learners will be able to plan biological evaluations, select and justify evidence and testing across the ISO 10993 series, assess biological risks, and prepare a defensible Biological Evaluation Report.
5000,00 LE
5000.0
EGP
5000,00 LE
| Responsável | Rehaf Foula |
|---|---|
| Última Atualização | 18/10/2026 |
| Membros | 1 |
Health
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1. Evaluation Foundations1Aulas ·
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1.1 WelcomeNovo
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2. Planning the Evaluation2Aulas ·
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2.1 Purpose of the Biological Evaluation PlanNovo
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2.2 Building a Device Evidence StrategyNovo
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3. Contact Categorization4Aulas ·
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3.1 Defining Body ContactNovo
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3.2 Classifying Contact DurationNovo
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3.3 Accounting for Exposure ChangesNovo
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3.4 Applying Contact CategoriesNovo
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4. Biological Endpoints3Aulas ·
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4.1 Mapping Relevant EndpointsNovo
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4.2 Endpoint Evidence and HazardsNovo
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4.3 When Endpoints Need TestingNovo
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5. Chemical Characterization2Aulas ·
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5.1 Role of Chemical CharacterizationNovo
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5.2 Defining Materials and ConstituentsNovo
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