integrate - External, clinical evaluation completes the overall picture
An essential requirement for the placement of medical products on the market is the clinical evaluation of the medical product by Clinical Research Organizations (CRO). Medical Safety Design assists you to organize this measure and integrates the results in the overall documentation.
A special focus of this phase lies on the integration of external findings in the requirements and realizations previously generated by Medical Safety Design.
The external, clinical evaluation by CROs focus on the factor safety, testing and evaluating for example the biocompability, toxicity or electrical safety of the medical product. Subsequently, Medical Safety Design integrates the results from the clinical evaluation in the current design process.
If necessary, the result may be a final review of the new medical product. By collaborating with independent CROs, Medical Safety Design is able to support the product manufacturer as regards the selection of and communication with CROs.