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Kursus med DNV Business Assurance
Introduction to biocompatibility for medical devices
Pris pr. deltager
Kursus
6.800,00 DKK
306,00 DKK
I alt ekskl. moms
7.106,00 DKK
25% moms
1.776,50 DKK
I alt inkl. moms
8.882,50 DKK
Se tilgængelighed
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 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. 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.
Foredragsholder: DNV Business Assurance
Varighed: minutter
Sprog: Dansk
Tilgængelighed:
Tilgængelig fysisk
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