IGBS-SBDG · Professional Course
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 modules
Structured curriculum
12 lessons
Online, self-paced
5,000.00 LE
Course fee
About this course
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.
Course curriculum
Module 1
1. Evaluation Foundations
- 1.1 Welcome
Module 2
2. Planning the Evaluation
- 2.1 Purpose of the Biological Evaluation Plan
- 2.2 Building a Device Evidence Strategy
- 2.3 Evaluation planning check
Module 3
3. Contact Categorization
- 3.1 Defining Body Contact
- 3.2 Classifying Contact Duration
- 3.3 Accounting for Exposure Changes
- 3.4 Applying Contact Categories
- 3.5 Contact categorization check
Module 4
4. Biological Endpoints
- 4.1 Mapping Relevant Endpoints
- 4.2 Endpoint Evidence and Hazards
- 4.3 When Endpoints Need Testing
- 4.4 Endpoint selection check
Module 5
5. Chemical Characterization
- 5.1 Role of Chemical Characterization
- 5.2 Defining Materials and Constituents
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