Webinar: The process for CE marking according to MDR and IVDR
The process for CE marking according to MDR and IVDR
The process for CE marking according to MDR and IVDR
Anmälningsdatum och eventdatum har passerat, men ta gärna del av presentationsbilderna från seminariet samt rapporterna här: Presentationsbilder, Sara Modig, Usify [...]
How can innovation initiatives lead to the implementation and spread of new products and working methods? This seems to be [...]
Klockan 10:30-12:00 den 17:e mars 2021 för de som tillhör den regionala noden Sydöstra sjukvårdsregionen i innovationsprogrammet Medtech4Health.
At 10: 30-12: 00 on March 17, 2021 for those connected with the regional node Southeast Healthcare Region in the Medtech4Health innovation programme.
WHO NCD Hard Talk webinar “Shifting the paradigm: NCDs, economics, and the push toward wellbeing”. Date: 17 March 2021, 13:00 [...]
Fullspäckad konferens med intressant innehåll och de bästa talarna inom området. Regulatory Summit 2021 blir en livesänd heldag! Konferensen kommer [...]
A conference packed with interesting content and the best speakers in the field. Regulatory Summit 2021 will be an all [...]
När du som tillverkare har kvalificerat din medicintekniska produkt enligt regelverken för medicintekniska produkter (Medical Device Regulation, MDR) eller för in vitro-diagnostik (In Vitro-diagnostik Regulations, IVDR) behöver du klassificera din produkt. Båda regelverken har en riskbaserad klassificering och din produkts klass styr många av vägvalen i din process för CE-märkningen.
When you as a manufacturer have qualified your medical device according to the regulations for medical device products (Medical Device Regulation (MDR) or for in-vitro diagnostics (In-Vitro Diagnostic Regulations, IVDR), you will need to classify your product. Both regulations have a risk-based classification and your product class governs many of the choices in your process for CE marking.