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.
Med mere end 70.000 certifikater udstedt på verdensplan, har DNV GL i årevis været den foretrukne certificeringspartner for mange internationale organisationer samt mindre og mellemstore virksomheder.
DNV GL's lokale tilstedeværelse, globale erfaring og anerkendte faglige kompetence på tværs af brancher bidrager til et godt samarbejde med vores kunder. Vi samarbejder med vores kunder for at hjælpe dem med at skabe værdi, og til at opfylde økonomiske, sociale og miljømæssige krav og udfordringer - uanset industri, branche eller størrelse på organisationen.
Gennem vores certificering, verificering, assessments og kursus ydelser, styrker vi vores kunders organisationer, produkter, medarbejdere, faciliteter og forsyningskæder.
Vores kerneområder er:
* Certificering af ledelsessystemer - Vi har udstedt mere end 70.000 certifikater.
* Supply Chain Management
* Produktcertificering - Sikre adgang til globale markeder og mere bæredygtige produkter.
* Verifikation
* Personcertificering- Sikre og skabe tillid til individuelle kompetencer.
* Uddannelse – Inden for kvalitet, miljø, arbejdsmiljø og audit
Vores mission er at beskytte liv, ejendom og miljø, da DNV GL gerne vil bidrage til en sikker og bærerdygtig fremtid.
