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Development of DIALIVE, a novel Liver Dialysis Device for the treatment of patients with Acute on Chronic Liver Failure (ACLF)

Deliverables

project web site

Report on design and content of project web site

Supply and Train clinical teams at individual sites about the use of DIALIVE

Supply and Train clinical teams at individual sites about the use of DIALIVE.

Incorporation of the Albutec Hepalbin™ filter into DIALIVE

Incorporation of the Albutec Hepalbin™ filter into DIALIVE

'First study subject approvals package' Ethics and Regulatory approvals for the SAFETY trial and for the EFFICACY trial

Also due at M21 'First study subject approvals package' Ethics and Regulatory approvals for the SAFETY trial and for the EFFICACY trial

Setting up the eCRFs and the associated database for the proposed SAFETY and EFFICACY clinical trials

Setting up the eCRFs and the associated database for the proposed SAFETY and EFFICACY clinical trials

Documentation and implementation of QMS per ISO 13485

Documentation and implementation of QMS per ISO 13485

Datamart logical data Model (data fusion) analysis of available data

Datamart logical data Model (data fusion) analysis of available data

Supply agreement for filters and purchase of Prismaflex for the different sites

Supply agreement for filters and purchase of Prismaflex for the different sites

Regulatory approval received for pre-CE mark Safety clinical trial and EFFICACY trial

Also due at M18 Details on regulatory approval received for gaining the pre-CE Mark SAFETY and EFFICACY trial

CE-mark for DIALIVE

Report on gaining CE mark for DIALIVE

Technical file and Design Dossier

report on Technical file and Design Dossier

Generation of Standard operating procedures and trouble shooting manual for DIALIVE

Generation of Standard operating procedures and trouble shooting manual for DIALIVE

Establish requirements of the datamart and data fusion

Establish requirements of the datamart and data fusion

Searching for OpenAIRE data...