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.
Performing a clinical evaluation