A clinical evaluation contains the analysis and evaluation of clinical data for a specific medical device with the objective of demonstrating the safety and performance in the clinical use. Relevant results from scientific literature, special investigations or human factors studies from post market surveillance upon sales launch and clinical experiences with similar medical devices will be taken into account and summarized from the clinical data. The clinical evaluation is also a living document that will be continuously updated during the product lifecycle.
Clinical evaluations are a key component of the regulatory approval process for medical devices. At confinis, we provide expert support in conducting clinical evaluations, ensuring that all regulatory requirements are met. Our team has extensive experience in designing and executing clinical evaluations that demonstrate the safety and efficacy of medical devices.
We assist clients in developing clinical evaluation plans, collecting and analyzing clinical data, and compiling comprehensive reports. Our rigorous approach ensures that clinical evaluations are conducted to the highest standards, enhancing the credibility of our clients’ submissions and increasing their chances of regulatory approval.
confinis can create a clinical evaluation for your medical device that is required for regulatory purposes or can help you define and implement relevant internal procedures.
How is it done?
Clinical data is composed of scientific literature, special investigations or human factors studies, postmarket surveillance as well as clinical experience with similar medical devices.
