Biocompatibility and Toxicological Risk Assessment of Medical Devices

Training duration: 1 Day

Course Overview

This focused one-day training program offers participants comprehensive knowledge on biocompatibility and toxicological risk assessment aligned with ISO 10993-1:2018 and ISO 10993-17:2002 standards. Gain practical insights into testing strategies, risk evaluation, and establishing allowable limits for leachable substances essential for medical device compliance. Learn from the notified body perspective to understand regulatory expectations and enhance your capability in product safety evaluation. The course also provides valuable networking opportunities with industry peers across diverse backgrounds. 

What Will You Learn? 

Participants will develop a hands-on understanding of:

• Categorizing and classifying medical devices based on contact type and duration
• Formulating biocompatibility testing strategies tailored to device characteristics
• Determining allowable limits for extractable and leachable substances from medical devices
• Conducting thorough toxicological risk evaluations of hazardous substances present in devices

By the end of this course, you will be equipped to: 

• Design compliant biocompatibility testing strategies
• Comprehend the notified body’s perspective on biocompatibility assessments
• Evaluate toxicological risks effectively in accordance with relevant ISO standards

Course Outline

• Introduction to Biocompatibility Basics
• Overview of Various Testing Strategies
• How to Develop an Effective Medical Device Testing Strategy
• Latest Updates and Revisions to ISO 10993 Standards
• Biocompatibility Assessment from a Notified Body Perspective (ISO 10993-1:2018)
• Toxicological Risk Assessment in Accordance with ISO 10993-17:2002
• Methodology for Establishing Allowable Limits of Leachable Substances
• Practical Exercise
• Online Examination

Who Should Attend? 

• Researchers
• Product Developers
• Toxicologists
• R&D Team Members
• Regulatory Managers
• Quality Assurance Personnel
• Engineers and Operational Managers
• Manufacturing Managers
• Service Providers in the Medical Devices Industry

Pre-requisites: Participants with basic knowledge of medical devices and biocompatibility, or experience in pharmaceutical toxicological evaluations, are preferred.

Learning & Career Benefits 

• Acquire skills to develop robust biocompatibility testing strategies
• Learn to establish scientifically justified allowable limits for leachable
• Gain insights into notified body expectations and assessment perspectives
• Enhance your competency in toxicological risk assessment for medical devices

Examination & Certification

Certification is granted upon successful completion of the instructor-led training program and passing the examination. The exam consists of 50 multiple-choice questions to be completed in 60 minutes and is open book to support knowledge application. Participants must achieve a minimum score of 60% (30 out of 50) to obtain the certificate of successful completion issued by TÜV SÜD South Asia.

Get in touch with us to know more.

Business address

TÜV SÜD Bangladesh (Pvt.) Ltd.

Update Tower, Level- 12, 8 & 14, 01 Shahjalal Avenue, Sector-06, Uttara Model Town, Dhaka-1230, Bangladesh

Tel: +88 02 58954115, 58954120, Ext-119

Email: [email protected]