Biocompatibility and Toxicological Risk Assessment of Medical Devices – The Notified Body Perspective

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.


This training will provide participants 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.


  • 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


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.


01 Day


Preferred to have basic knowledge in Medical Devices and Bio-compatibility or experience in medical device, Pharmaceutical toxicological evaluations.

EXAM DETAILS (Duration, Pattern)

Examination – 1 hour, Objective-type


Certificate on successful completion of the Training.



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