Introduction to biocompatibility for medical devices
This training will provide participants with an insight into biocompatibility, risk-based approach ISO 14971:2019, on the ISO 10993-1 and ISO 10993-18 standards. It will be helpful for Quality and Regulatory people who are involved in preparing Technical files and Design Dossiers and gives a hands-on knowledge of biocompatibility assessment, testing strategy and risk assessment approach.
About Introduction to biocompatibility for medical devices
Why this course:
The focus on biocompatibility has become stronger as the ISO standards are updated and the MDR is now in place. This course will give you an introduction and also give a route, the Biological Evaluation Plan, as to how to work with this task both from an ISO 10993-1 level and the MDR 2017/745 level. Chemical characterization is mandatory and we will go through this in more detail.
Who should attend:
QA/RA, D&D, Clinical as well as suppliers of raw material.
What will you learn:
In this one day’ training you will get an overview of the requirements and the guidance documents in order for you to be able to establish a well-prepared Biological Evaluation Plan.
Content:
Module 1 (1 day) – Introduction to biocompatibility for medical devices with a risk-based approach:
- ISO 10993-1 and ISO 14971
- Biological Evaluation plan and MDR GSPR §10
- US/FDA status
- Raw materials, suppliers and manufacturers with respect to process aids and change control
- ISO 10993-18 – what testing scenario to choose and why
- Requirements on the test houses
Trainers:
The course is tutored by the below experienced trainer:
- Anette Sjögren, MSc Biomedicine, Regulatory expert, 35 years in industry medical devices and pharmaceuticals, member of the international standardization work within medical devices.
Are you looking for a customised course?:
Content of the course can be changed and modified depending on the need of the customer for private/inhouse courses.
Please contact us for more information.
About Introduction to biocompatibility for medical devices
Why this course:
The focus on biocompatibility has become stronger as the ISO standards are updated and the MDR is now in place. This course will give you an introduction and also give a route, the Biological Evaluation Plan, as to how to work with this task both from an ISO 10993-1 level and the MDR 2017/745 level. Chemical characterization is mandatory and we will go through this in more detail.
Who should attend:
QA/RA, D&D, Clinical as well as suppliers of raw material.
What will you learn:
In this one day’ training you will get an overview of the requirements and the guidance documents in order for you to be able to establish a well-prepared Biological Evaluation Plan.
Content:
Module 1 (1 day) – Introduction to biocompatibility for medical devices with a risk-based approach:
- ISO 10993-1 and ISO 14971
- Biological Evaluation plan and MDR GSPR §10
- US/FDA status
- Raw materials, suppliers and manufacturers with respect to process aids and change control
- ISO 10993-18 – what testing scenario to choose and why
- Requirements on the test houses
Trainers:
The course is tutored by the below experienced trainer:
- Anette Sjögren, MSc Biomedicine, Regulatory expert, 35 years in industry medical devices and pharmaceuticals, member of the international standardization work within medical devices.
Are you looking for a customised course?:
Content of the course can be changed and modified depending on the need of the customer for private/inhouse courses.
Please contact us for more information.