TBMED Open Call: Support for CPoC or clinical investigations
TBMED launches an Open Call with the objective of providing support to developers which aim to perform a Clinical Proof of Concept (CPoC) or clinical investigation with an innovative high risk medical device.
Due to the entry into force of the European regulation MDR 2017/745 in May 2021, quality, safety and performance requirements along the whole technology development chain of medical devices have increased in order to ensure a high level of health protection for patients and users.
TBMED aims to establish an Open Innovation Testing Bed (OITB) specialized in the development of high risk medical devices (MDs) (Class IIb or Class III) by providing an integral service to accelerate the development of MDs, reducing time to market, covering technology development from TRL4 (proof of concept in small animals) to TRL7 (clinical investigations) and offering at the same time additional business management services to companies that require those.
Within the scope of this Open Call, applicants can apply for the following services:
• Advisory sessions to address the design of a clinical proof of concept (CPoC)
• Consultancy for the development of multinational clinical medical device investigations
• Support for regional or multinational clinical investigations in order to determine feasibility and performance of a medical device including services such as design, clinical investigator identification, project management, regulatory and ethical submissions, data management and statistics, monitoring, etc.
More detailed information is available in the application guide below.
The call is now open!
Deadline for submission of applications extended: March 1, 2021 23:59 CET
Please use the Word document (availabe for download below) for your application.
Should you have any questions, please contact firstname.lastname@example.org