Overview and Assessment
Overview and Assessment
Bio-compatibility is the biological evaluation of Medical Devices in compliance with the standard ISO 10993-1: 2018. The standard puts forth the requirements pertaining to biological evaluation of medical devices, general principles governing biological evaluation, categorization of medical devices, evaluation, additional data, risk assessment and interpretation and the biological tests followed by gap analysis for the medical devices based on categorization.
The Bio-compatibility assessment in perspective of Notified Body will be discussed in this training program which is a vital information for manufacturers during evaluation of technical Files and Design Dossiers by Notified bodies. The basics and importance of Toxicological risk assessment in compliance with ISO 10993-17: 2002 will also be discussed during the session which is an essential information required by the Notified Body. This standard explains the method for determination of allowable limits for substances leaching out of Medical Devices and helps in estimating allowable limits through a systematic approach towards toxicological risk evaluation of hazardous substances present in Medical Devices.
Duration: 1 - day course
At the end of this course, participants will be able to:
Gain an insight of ISO 10993-1: 2018, (Biological Evaluation of Medical Devices – Evaluation and testing within a risk management process and Medical devices - Quality management systems) and ISO 10993-17: 2002 (Biological Evaluation of Medical Devices – Establishment of allowable limits for leachable substance). It will be helpful for Quality and Regulatory people who are involved in preparing Technical files and Design Dossiers. It gives a hands on experience/knowledge of Bio-compatibility assessment, testing strategy and Risk Assessment Approach.
Topics to be covered in this course include:
• Basic Bio-compatibility
• Bio-compatibility Testing Strategy Overview
• Updates on Revised Standards
• Bio-compatibility Assessment – Notified body way – ISO 10993-1: 2018
• Toxicological Risk Assessment – ISO 10993-17: 2002
Participants will learn through lectures, case studies, group exercises and discussions.
There will be an examination at the end of the course – 1 hour, Objective-type.
This course is specially designed for:
• Medical Device Manufacturers
• Regulatory Professionals
• Quality Assurance Professionals
• Toxicologists involved in Bio-compatibility Studies
• Internal and external Auditors
• Consultants and anyone involved with the implementation of the standard.
Preferred to have basic knowledge in Medical Devices and Bio-compatibility or experience in medical device, Pharmaceutical toxicological evaluations.
The course content and structure are designed by the domain experts from TÜV SÜD.
With immense experience and knowledge in the relevant standards, our team of product specialists and technical experts at TÜV SÜD, developed the course content based on current business landscape and market requirements.
To enroll, please fill out the form on the webpage accordingly.
Please contact us at [email protected] for more details.
Yes, you will receive a certificate of completion at the end of the Biocompatibility and Toxicological Risk Assessment of Medical Devices – The Notified Body Perspective course.
The Biocompatibility and Toxicological Risk Assessment of Medical Devices – The Notified Body Perspective course content and structure are designed by the domain experts from TÜV SÜD. With immense experience and knowledge in the relevant standards, our team of product specialists and technical experts at TÜV SÜD, developed the Biocompatibility and Toxicological Risk Assessment of Medical Devices – The Notified Body Perspective course content based on current business landscape and market requirements. The experts also undergo relevant upskilling programmes, benefitting from TÜV SÜD’s 150 years of expertise and global heritage.