Your introduction to the Biological Evaluation of Medical Devices According to ISO 10993
In this eLearning course, you will learn how to systematically plan, assess, and document biocompatibility in the context of risk management, material characterization, and regulatory requirements (including the MDR and the ISO 10993 series). Through concise video lessons, narrated presentations, practical exercises, and interactive quizzes, you will build solid, practice-oriented knowledge step by step.
Why choose our eLearning?
- Industry Expertise: Our course has been developed by experienced specialists in biological evaluation to ensure you gain practical knowledge that can be directly applied in your daily work.
- Flexible Learning: Study at your own pace, whenever and wherever it suits you. Our eLearning approach allows you to fit professional development around your schedule while benefiting from high-quality training content.
- Interactive Learning Modules: Learning should be engaging. Our interactive modules combine practical examples, case studies, and quizzes to actively involve you throughout the learning process.
- Certificate of Completion: Upon successfully completing the course, you will receive a certificate confirming your qualification.
- Content
- Biocompatibility in the context of risk management
- Biological evaluation according to ISO 10993-1
- Materials and manufacturing processes from a biocompatibility perspective
- Degradation products & particles
- Toxicological characterization
- Biological testing
- Interactive learning modules
Your Learning Environment
After registration, you will receive access to our Learning Management System (LMS), allowing you to complete the training at your own pace.
Access period: 180 days
After successfully completing the course, you will receive your certificate of completion as proof of qualification.
- How you benefit
- Gain Confidence: Understand how biocompatibility is systematically derived from risk management in a compliant and audit-ready manner.
- Make Informed Decisions: Learn when existing data are sufficient, when biological testing is required, and how to justify biological endpoints.
- Master Documentation: Prepare content for Technical Documentation, Biological Evaluation Reports, and CAPA documentation with confidence.
- Work More Efficiently: Benefit from practical checklists and templates that support implementation in your day-to-day projects.
- Methods
Trainer input, real-life review scenarios, case studies, practical exercises, and interactive learning elements.
- Target Audience
- (Junior) Regulatory Affairs, Quality Management, R&D, Clinical Affairs, and PMCF professionals
- Professionals who are new to biocompatibility or transitioning into the field
- Members of project and product teams responsible for implementing the requirements of the ISO 10993 series
