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ISO 10993-1 Biological Evaluation of Medical Devices

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
5,000.00 LE
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Responsible Rehaf Foula
Last Update 10/18/2026
Members 1
Health
  • 1. Evaluation Foundations
    1Lessons ·
    • 1.1 Welcome
      New
  • 2. Planning the Evaluation
    2Lessons ·
    • 2.1 Purpose of the Biological Evaluation Plan
      New
    • 2.2 Building a Device Evidence Strategy
      New
  • 3. Contact Categorization
    4Lessons ·
    • 3.1 Defining Body Contact
      New
    • 3.2 Classifying Contact Duration
      New
    • 3.3 Accounting for Exposure Changes
      New
    • 3.4 Applying Contact Categories
      New
  • 4. Biological Endpoints
    3Lessons ·
    • 4.1 Mapping Relevant Endpoints
      New
    • 4.2 Endpoint Evidence and Hazards
      New
    • 4.3 When Endpoints Need Testing
      New
  • 5. Chemical Characterization
    2Lessons ·
    • 5.1 Role of Chemical Characterization
      New
    • 5.2 Defining Materials and Constituents
      New