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.
5 000,00 LE
5000.0
EGP
5 000,00 LE
| Responsable | Rehaf Foula |
|---|---|
| Dernière mise à jour | 18/10/2026 |
| Membres | 1 |
Health
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1. Evaluation Foundations1Leçons ·
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1.1 WelcomeNouveau
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2. Planning the Evaluation2Leçons ·
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2.1 Purpose of the Biological Evaluation PlanNouveau
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2.2 Building a Device Evidence StrategyNouveau
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3. Contact Categorization4Leçons ·
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3.1 Defining Body ContactNouveau
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3.2 Classifying Contact DurationNouveau
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3.3 Accounting for Exposure ChangesNouveau
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3.4 Applying Contact CategoriesNouveau
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4. Biological Endpoints3Leçons ·
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4.1 Mapping Relevant EndpointsNouveau
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4.2 Endpoint Evidence and HazardsNouveau
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4.3 When Endpoints Need TestingNouveau
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5. Chemical Characterization2Leçons ·
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5.1 Role of Chemical CharacterizationNouveau
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5.2 Defining Materials and ConstituentsNouveau
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