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
| Verantwortlich | Rehaf Foula |
|---|---|
| Letzte Aktualisierung | 18.10.2026 |
| Mitglieder | 1 |
Health
-
1. Evaluation Foundations1Lektionen ·
-
1.1 WelcomeNeu
-
-
2. Planning the Evaluation2Lektionen ·
-
2.1 Purpose of the Biological Evaluation PlanNeu
-
2.2 Building a Device Evidence StrategyNeu
-
-
3. Contact Categorization4Lektionen ·
-
3.1 Defining Body ContactNeu
-
3.2 Classifying Contact DurationNeu
-
3.3 Accounting for Exposure ChangesNeu
-
3.4 Applying Contact CategoriesNeu
-
-
4. Biological Endpoints3Lektionen ·
-
4.1 Mapping Relevant EndpointsNeu
-
4.2 Endpoint Evidence and HazardsNeu
-
4.3 When Endpoints Need TestingNeu
-
-
5. Chemical Characterization2Lektionen ·
-
5.1 Role of Chemical CharacterizationNeu
-
5.2 Defining Materials and ConstituentsNeu
-