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.

  • Design Control

    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.
  • Risk Management

    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.
 

 

All the partners of the Neurimp project

  • Clinical Evaluation

    needs to take place to verify the clinical safety and performance of the medical device and means the assessment and analysis of clinical data. It is mandatory for all medical devices to conduct a clinical (data) evaluation in order to demonstrate conformity with the essential requirements of the Medical Device Directive (MDD) 94/42/EEC. Qserve will provide training on the requirements, execute a systematic literature search, include adverse event databases and take the lead in writing the clinical evaluation report.
  • Technical Documentation

    from all partners must be collected. Every partner must be aware what Regulatory Compliance documentation will be required to fill the Design History File (DHF), including regulatory documents. Additionally, Qserve will prepare a Summary Technical Documentation (STED) that can be used for future regulatory submission. Qserve provides training on the requirements, gathers required technical/scientific validation information and assist with preparing the DRAFT STED file.
Senior Consultant and Biocompatibility Specialist Sonja van der Meer is involved in this research project.

 

More information about the objectives of this project: NEURIMP | FLYER  | VIDEO

 

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