About the project
Research is done to determine the optimal physical parameters required by biomimetical endoneural tubes to pave for an efficient regeneration of both sensory and motor axons. Qserve Group is advising the partners about the medical device regulations governing all processes within NEURIMP.
means that the design of the medical device must meet the essential Medical Device Directive (MDD) requirements. Qserve will write the design process procedures, provide a training and monitor the output to verify the implementation.
plays an important role in the development of medical devices and their market access as the classification of medical devices is a ‘risk based’ system, taking account of the potential risk associated by looking at the vulnerability of the human body and the user of the medical device. Qserve will prepare a Risk Management procedure, provide training, set up the Risk Management plan and prepare the Risk Management report.
Biological and Safety Studies
are necessary to protect humans from potential biological risks arising from the use of the medical device. Biological safety of the device needs to be evaluated by assessing its biocompatibility. Safety issues regarding biocompatibility during the development, production and use of the medical device are to be detected and managed. Qserve will therefore prepare procedures for biological safety evaluation and provide training on the requirements and.