CLINICAL EVALUATION

Clinical Evaluation is a procedure that involves assessing all clinical data of medical devices, and checking if there is adequate clinical evidence required for the relevant regulations. Kite Medtech assists to evaluate your device and fulfill the requirements.  We are experts in evaluating high-risk devices according to EU MDR Regulation 2017/745 and 2017/746. We have assessed key documents for evaluating all the medical devices. Though there are many ways to conduct clinical evaluation and generate clinical evaluation reports, the clinical data has to be accepted by regulatory bodies. Devices have to be evaluated in accordance with certain clinical protocols which define primary & secondary endpoints. The protocol includes sample size, study design, and data analysis plan. 

We also work in creating clinical protocol with regulatory strategies, clinical evaluation reports, and combining clinical operations with Quality Management Systems (QMS) of various companies. 

Biostatisticians, Medical Physicians, Engineers, Writers, Radiologists, and Quality & Regulatory experts in our crew are assisting medical device companies and evaluating clinical data to work on the clinical evaluation reports.

Here are some services we offer in our company for medical evaluation plans. 

  • Clinical Evaluation Plan
  • Clinical Development Plan
  • Literature Search Protocols
  • Literature Search Reports
  • State of the Art Evaluation
  • Bechmark product evaluation
  • Clinical Evaluation Report (CER)
  • Routine clinical evaluation report updates
  • Clinical Strategy
  • Biological Equivalency
  • Technical Equivalency
  • Clinical Equivalency
  • Equivalency Assessments
  • Expert Clinical Evaluation Reviews
  • Identifying and engaging with KOL’s
  • Handling complaints on clinical evaluation and setting up relevant systems
  • Working on Post Market Clinical Follow-up protocol (PMCF)

Our team takes complete responsibility for producing quality results for companies in the clinical field. Also, our partners receive a satisfying experience. We provide their documents & reports on time and make their work easier.