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. The MDR requests not only biocompatibility, but also a toxicological risk assessment of certain substances that may be of concern. This will also be introduced. Chemical characterization is mandatory and we will go through this in more detail. The general in-vitro and in-vivo standards will also be introduced.
Who should attend:
QA/RA, D&D, Clinical as well as suppliers of raw material.
What will you learn:
In this three days’ 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.
Attend the full three days training for the complete overview or sign up for individual modules at your choice. See content below.
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
Modul 2 (1 day) - Introduction to mandatory requirements:
- ISO 10993-18 – what testing scenario to choose and why
- Requirements on the test houses
- ISO 10993-17 – toxicological thresholds and toxicological risk assessment
- Life-cycle studies
Module 3 (1 day) – The ISO 10993 series in brief:
- Overview of requirements in ISO 10993-2-12 and ISO 10993-23
The three days course is finalized with a written exam. The exam is completed as an open book exam.
The course is tutored by the below experienced trainers:
- Anette Sjögren, MSc Biomedicine, Regulatory expert, 35 years in industry medical devices and pharmaceuticals, member of the international standardization work within medical devices.
- Charlotte Trotzig, PhD polymer chemistry, Biocompatibility expert, 25 years in industry and member of the ISO 10993 working group.
- Helena Nerell, MSc Toxicology, Expert in toxicology, 30 years in industry within toxicology for medical devices and pharmaceuticals.
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.