Biological Evaluation of Medical Devices - How to Succeed in Your Notified Body Assessment
This course provides a comprehensive and practice oriented introduction to the biological evaluation of medical devices according to the ISO 10993 as well as ISO 18562 series and the regulatory requirements of the EU MDR. Participants learn how to apply the principles of biological safety within a risk based framework aligned with ISO 14971. The training explains the tiered evaluation approach, from material characterization and literature review to defining testing strategies and preparing scientifically sound biological evaluation plans and reports. Practical examples and insights into Notified Body expectations help participants navigate increasingly stringent conformity assessments with confidence.
Course Outline
- Regulatory framework for biological safety under the EU MDR
- Structure and application of ISO 10993 1, ISO 18562 and related standards
- Integration with ISO 14971 risk management
- Material characterization and hazard identification
- Biological risk assessment and gap analysis
- Testing strategies and justification
- Development of biological evaluation plans and reports
- Interfaces with design verification and technical documentation
- Practical examples and typical Notified Body findings
Learning Outcomes
Apply Regulatory Requirements for Biological Safety
- Regulation (EU) 2017/745 (EU MDR)
- ISO 10993 1, ISO 18562 and related standards
- Integration with ISO 14971 risk management processes
Implement the Biological Evaluation Process
- Understanding terminology and key definitions
- Conducting material characterization according to ISO 10993 18 and 19
- Performing biological risk assessments and identifying information gaps
- Determining when analytical or biological testing is required
- Establishing a structured biological evaluation plan
- Summarizing results in a scientifically sound biological evaluation report
Recognize Interfaces and Responsibilities
- Linking biological evaluation, design verification, and risk management
- Identifying relevant stakeholders across R&D, Quality, Regulatory Affairs, suppliers, and service providers
- Ensuring alignment with General Safety and Performance Requirements (GSPRs)
Evaluate Strategies and Practical Examples
- Comparing different approaches to biological evaluation
- Analyzing real world examples of biological safety assessments
- Understanding typical challenges raised by Notified Bodies and how to address them
Who Should Attend
Why You Should Attend
This course is ideal for professionals who need a clear, structured, and practical understanding of biological evaluation under the ISO 10993 and/or ISO 18562 series. It equips participants to develop robust evaluation plans, identify testing needs, and prepare defensible biological evaluation reports that meet MDR requirements. The training provides practical insights into Notified Body expectations, helping participants avoid common pitfalls and confidently navigate conformity assessment.
Who Should Attend
- Medical device manufacturers
- Authors of technical documentation
- Regulatory Affairs specialists
- Quality Management professionals
- Research and Development staff
- Service providers supporting biological evaluations
- Suppliers involved in material selection or component manufacturing
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