Training: Basic Biocompatibility

Practical Perspective and Regulatory Aspects

Speakers: Monica Grekula and Lina Burman
Duration: 2 x 3 hours
Date: November 6th and 11th 2025, Online
2 × 8:00 AM – 11:00 PM US Eastern Daylight Time (EDT)
2 × 2:00 PM – 5:00 PM Central European Time (CET)

• Training Objectives

  By attending this training, you will gain a foundational understanding of biocompatibility requirements and related challenges. This knowledge will help you minimize the risk of:

  • Costly and time-consuming errors in material selection
  • Repeating biocompatibility testing
  • Adverse events related to material changes
  • Audit deviations linked to material modifications
  • Regulatory questions from Notified Bodies and Authorities during submissions
    

  This course will enhance your understanding of biocompatibility to help you:
  

  • Ensure timely integration of biocompatibility considerations during product development
  • Communicate effectively with biological evaluation teams and testing laboratories
  • Confidently review biocompatibility documentation for regulatory submissions and clinical evaluations

  The course also serves as an introduction for those new to the field of biological evaluation. Key considerations from ISO/FDIS 10993-1:2025 will be covered, providing essential context for current and emerging biocompatibility requirements.

• Training Content

  • Introduction to biocompatibility: definitions and links to other processes
  • Overview of the ISO 10993 series
  • ISO 10993-1: General principles and risk-based approach (current and FDIS 2025 version)
  • Identifying biological hazards and relevant biological endpoints
  • Information requirements for biological evaluations
  • Basic considerations for material selection and supplier management
  • Essentials for planning and coordinating with test laboratories
  • Triggers for updating biological evaluations
  • Key biocompatibility aspects under EU MDR 2017/745 and GSPRs
  • What Notified Bodies expect in submissions
  • Global regulatory perspectives
  • Practical exercises and case studies

• Training Format

  • Presentations with interactive discussions
  • Group and individual exercises
  • End of training assessment

• Target Audience

  This course is designed for beginners and those with basic biocompatibility needs. It is ideal for professionals who require a foundational understanding of biocompatibility, including:
  

  • Project managers and engineers
  • Regulatory affairs managers
  • Quality engineers
  • Sustaining engineers
  • Professionals involved in vigilance investigations or clinical evaluations
  • Individuals new to biological evaluations

• Price

  EUR 625, including course material and certificate