Biocompatibility & Toxicological Risk Assessment of Medical Devices Training Course

Face to face Training1 DayIntermediateVirtual Classroom

This training programme aims to provide participants with insights into ISO 10993-1:2018 and ISO 10993-17:2002 standards. The participants receive a hands-on understanding of the biocompatibility assessment, testing strategy and toxicological risk assessment approach required for demonstrating compliance with the standard requirement.

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

  • Categorise and classify the medical device based on contact and duration
  • Testing strategies for a medical device
  • Determine allowable limits of substances Extractable/leachable out of medical devices
  • Conduct risk evaluation of hazardous substances present in medical devices


  • Product developers
  • Toxicologists
  • R&D team members
  • Regulatory managers
  • Quality Assurance personnel


  • Engineers
  • Operational managers
  • Manufacturing managers
  • Service providers associated with the medical devices industry.
  • Comprehensive knowledge of biocompatibility and toxicological risk assessment for ISO 10993-1:2018 standard
  • Biocompatibility testing strategies
  • Testing strategy and risk assessment approach concerning ISO 10993-1:2018 standard and ISO 10993-17:2002 standard requirements
  • Understand how to establish allowable limits for leachable substances
  • Networking opportunities with peers from varied backgrounds
  • Basics of Biocompatibility
  • What are the different testing strategies?
  • Creating a medical device testing strategy
  • Latest updates on revised standards
  • Biocompatibility Assessment – The Notified Body Perspective – ISO 10993-1:2018
  • Toxicological Risk Assessment according to ISO 10993-17:2002
  • Establishing allowable limits of leachable substances
  • Exercise
  • Course delivered by one of TÜV SÜD's leading industry experts
  • Small class sizes enhance trainer-delegate relationship
  • Receive globally recognised TÜV SÜD certificate upon completion

Participants having basic knowledge in Medical Devices and Biocompatibility or holding an experience in pharmaceutical toxicological evaluations are preferred.

TÜV SÜD additionally offers the opportunity to deliver this training as a dedicated in-house course, delivered solely to your organisation to meet your needs and requirements. To receive a quote and find out more information, please contact us at [email protected].

Net Price (excl. VAT)
from£ 699.00

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Book training course Biocompatibility & Toxicological Risk Assessment of Medical Devices Training Course
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From 17/09/24
Virtual Classroom
£ 699.00 add. VAT

Course No.

1 Day

Show Agenda

Virtual Classroom


Net Price
£ 699.00
plus VAT:
£ 139.80

Total Price (inc. VAT)
£ 838.80