Clinical Validation

In the field of medical devices the term clinical validation is very topical.
Clinical validation is a fundamental step in obtaining the CE marking for any medical device, in order to demonstrate its clinical efficacy.
The Meddev Guideline 2.7.1 Rev. 4 and the new European Regulation on Medical Devices (EU MDR 745/2017) emphasize this theme even more.
The clinical evaluation is based on two fundamental elements: clinical bibliographic evaluation and clinical experimentation.
Both require specific professionalism and a heterogeneous team, which also includes clinical staff, to ensure the reliability, scientificity and objectivity of the conclusions.
  • Bibliographic evaluation: The MAYTAL team, composed of clinicians who for years collaborate with companies in the sector, engineers and biologists, with years of experience in the field of medical devices. This team of people possesses consolidated skills, professionalism and methods, widely tested and validated by various Notified Bodies, which guarantee maximum objectivity, scientificity, competence and reliability.
  • Clinical studies: The MAYTAL team, through the clinical and methodological skills close to the Medical Device world, is able to assist in establishing the method of defining a clinical trial (protocol, definition of outcomes, etc.) up to the conduct of the clinical study, through the partnership with a reputable CRO (Contract Research Organization).
In particular:
  • Comparative analysis relative to products on the market and GAP evaluation to be validated clinically
  • Drafting of the clinical bibliographic validation protocol
  • CER (Clinical Evaluation Report)
  • Drafting of clinical trial protocol and related documents (CRFs, clinician brochures, etc.)
  • Drafting reports with ethics committees
  • Drafting reports with competent authorities on adverse event management
  • Management of study monitoring
  • Data management, statistical processing
  • Final study report