Clinical assessment and investigation

During your product development, you reach the clinical assessment stage, but how do you address this complex problem?

Nex’Med has the solution. A simple and accurate service takes the form of a comprehensive clinical assessment report (for medical devices) or performance assessment report (for in vitro diagnostic devices), based on a methodology meeting regulatory requirements (2.7 MEDDEV .1 rev4).

Nex’Med allows you to assess the performance and safety of your medical devices in an objective and reproducible manner by:

  • Analysis of comparable products;
  • A systematic and comprehensive literature search;
  • Selection and analysis of articles and relevant clinical outcomes;
  • A results summary in line with demands about the product;
  • Closure with risk management, information provided to users and post-market surveillance;
  • If appropriate, conduct of dedicated clinical trials, from design and implementation testing to analysis and presentation of results.

Nex’med is provided as one-off support on certain methodology points or as an outsourced services package.

Business cases

Case 1

Performing a clinical evaluation