Biocompatibility & Toxicological Risk Assessment of Medical Devices Training Course
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
Who Should Attend?
Research
- Product developers
- Toxicologists
- R&D team members
- Regulatory managers
- Quality Assurance personnel
Engineering/Administration
- Engineers
- Operational managers
- Manufacturing managers
- Service providers associated with the medical devices industry.
Objectives
- 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
Agenda
- 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
Benefits
- 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
Prerequisites
Participants having basic knowledge in Medical Devices and Biocompatibility or holding an experience in pharmaceutical toxicological evaluations are preferred.
FAQs
TÜV SÜD tests and certifies through its Notified Bodies medical devices and their manufacturers. TÜV SÜD Academy UK offers trainings in the field of medical devices.
The neutrality and independence of the conformity assessment procedures carried out by TÜV SÜD must be maintained. In the interest of our customers, hence the seminars of TÜV SÜD Academy do not contain any product-specific, process-related or company-specific content or solutions that could fulfill the function of individual consulting.
In case of any questions or uncertainties, please do not hesitate to contact us.