Overview

Navigate Course Details

Course Overview

  • Duration: 8 hours
  • Cost: $950 USD

*Book now to get a 20% discount.

Biocompatibility is an important factor in the development of medical devices, verifying that materials used in devices do not pose biological risks to operators and patients. In this training course, participants will gain an extensive understanding of biocompatibility, covering applicable regulatory frameworks, material selection, surface modification, sterilization, and real-world applications.

Note: This training course is currently only available in English.

This training course covers the following topics:

  • Introduction to biocompatibility
  • Applicable regulatory frameworks
  • Material selection
  • Interactions between materials and the body
  • Sterilization and its impact on biocompatibility
  • How to write a biological evaluation
  • Real-world applications of biocompatibility requirements
  • Future trends in biocompatibility

Learning Objectives
After taking this course, participants will obtain a better understanding of the following areas:

  • Regulatory requirements and standards for biological evaluation.
  • Real-world application of biocompatibility standards.
  • Strengthening compliance with regulatory requirements.
  • Verifying the biological safety of materials using a risk-based approach.

Ideal Target Audience
While this course is open to everyone, it is particularly valuable for professionals involved in the design, development, and regulatory approval of medical devices, including:

  • Biomedical engineers
  • Regulatory affairs specialists
  • Quality assurance professionals
  • Research and development scientists

Instructor Information
Our instructors are experienced professionals with extensive regulatory knowledge and multiple years of experience working in a Notified Body. They will provide you with guidance on conducting biological evaluations and mitigating biocompatibility risks in a manner that aligns with applicable regulatory requirements.

David Heil is a regulatory expert with five years of experience in a Notified Body. With a background in biology and medical engineering, he has supported manufacturers of implants and surgical instruments in quality management, design, and development. His key areas of expertise include risk management, process validation, and microbiology. Since joining CSA Group, David has played a key role in establishing new review processes in the medical sector.

Jonathan Barber is a regulatory Project Planner with five years of experience in a Notified Body. He has provided certification expertise for clients in Europe, Asia, the U.S., and Australia under MDSAP, MDR, and ISO 13485. Furthermore, as a Team Leader for the “Major Corporations” group, which supported large clients with multiple high-risk devices, he coordinated subject-matter experts responsible for the review of the biological evaluation.

Benefits of Our Training

  • Expert Instructors: Our trainers have a deep understanding of certification processes and have worked with world-class manufacturers.
  • Gain Confidence: Equip your team with the confidence to navigate regulatory requirements and achieve compliance.
  • Private or Public: We offer both public and private courses. For organizations with 10 or more participants, we can provide private training tailored to your business needs. For smaller groups, our public courses are designed to cover a range of complex topics.
  • Hands-On Learning: Engage in practical exercises and case studies to reinforce your understanding.
  • Certificate: Earn a Certificate of Completion upon successful completion of the course.

Go to the Top