Our Services

Medical Device Clinical Data Evaluation, Clinical Research and Performance Evaluation for in vitro (used outside the body) Medical Diagnostic Devices require speed, expertise and experience.  

Clinical study is the most expensive and important part of product development and post-market surveillance studies. It should be planned carefully and wisely in order to prevent the study from being considered inadequate and repeated.

Our experts who have specialized in Medical Devices and in vitro Medical Diagnostic Devices and who are well-equipped in laws and Clinical Research assist you in performing scientifically valuable Clinical Studies and preparing documents for which legal approvals can be obtained easily by taking the related laws into consideration. Our specialized team provides you with support during the entire clinical research and clinical data evaluation process with regard to clinical and legal regulations, approvals of products and clinical research, biostatistics and data management. 

When doing our jobs, we attach importance to 

  • Protection of data, 
  • Provision of sustainability with long-term solutions, 
  • Professional information sharing, and
  • Accurate and timely delivery of the project in one go.

With his staff that has specialized in medical devices and follows innovations in the sector and changing requirements closely, DeSia provides the following for Medical Devices:

  • Preparation of a clinical data evaluation report (CDE) within the framework of Meddev 2.7.1 Rev 4 guidelines and 2017/745 MDR, 
  • Planning and implementation of Post-Market Clinical Follow-up (PMCF) studies. 

And for clinical studies prior to marketing and for in vitro Medical Diagnostic Devices, DeSia provides 

  • All services regarding Clinical Performance Evaluation.

With his international collaborations, DeSia also provides the opportunity for your Clinical Studies to be performed in different countries.