Denne leverandør er ikke tilknyttet Youandx. Hvis du ønsker at booke fra den leverandør, vil du blive omdirigeret til deres hjemmeside, hvor du bliver nødt til at udfylde din booking.
course 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
Anmeldelser
DNV Business Assurance har ingen synlige ratings på dette tidspunkt.
Galleri
DNV Business Assurance har ingen billeder i galleriet.
