Biocompatibility and Toxicological Risk Assessment of Medical Devices – The Notified Body Perspective Training
- 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.
What will you learn?
At the end of the course, you will:
- 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)
Course outline
In this program, you will learn the following:
- 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
Who should attend?
The 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
Prerequisites
Preferred to have basic knowledge in Medical Devices and Bio-compatibility or experience in medical device, Pharmaceutical toxicological evaluations.
Learning & Career Prospects
Biocompatibility assessment professionals are essential in various fields, particularly in the medical device, pharmaceutical, and biotechnology industries. Career prospects include:
- Regulatory affairs specialist
- Qualiy assurance manager
- Compliance officer
- Internal/external auditors
Trainer Profile
The course content and structure are developed by the domain experts from TÜV SÜD. With immense experience and knowledge of the relevant standards, our team of product specialists and technical experts at TÜV SÜD have developed the course content based on the current business landscape and market requirements.
Examination & Certification
Upon completing the course, you will receive a certificate from TÜV SÜD.
FAQ
1. Can I also attend e-learning courses on top of attending the Biocompatibility and Toxicological Risk Assessment of Medical Devices – The Notified Body Perspective course?
Yes, you can register for any e-learning course at TÜV SÜD.
2. How do I enroll for the Biocompatibility and Toxicological Risk Assessment of Medical Devices – The Notified Body Perspective course?
To enroll, please click on "Buy now" and check out your cart.
3. What is the Biocompatibility and Toxicological Risk Assessment of Medical Devices – The Notified Body Perspective course methodology?
Participants will learn through lectures, case studies, group exercises and discussions.
4. Can I get a refund if I cancel my enrolment?
- If you communicate the cancellation to us by email within 14 days before the confirmed training date, we will not provide a refund for the training.
- If you communicate the cancellation to us by email more than 14 days before the confirmed training date, we will provide a 50 % refund for the training.
5. Are there any tests in the middle of the course?
There are no in-between assessments, but case studies will be included in the Biocompatibility and Toxicological Risk Assessment of Medical Devices – The Notified Body Perspective course.