Genelife Clinical Research has experience in conducting Medical device and drug device combination clinical trials. From clinical research perspective, medical devices can be classified into four main categories-Therapeutic (Whether active or inactive), Non-therapeutic-non-diagnostic (Accessory), Diagnostic and Contraceptive medical devices.
The therapeutic medical devices, which mainly require clinical evaluation, have mainly two types, Implantable and external.
The Clinical Trials of medical device’s are complex in comparison to drug. So, one has to design the study to overcome the constrains in medical device clinical research, especially pertaining to comparability and establishment of universal outcomes. There is no perfect control in a medical devices study. Moreover, as there is no “Absolute safety and efficacy” available from experimentation in healthy human subjects, the outcomes of studies remain majorly study specific. Applicability of the trial outcomes to real world is grossly limited.
Medical device clinical trials can have several design options. The first is variation of the hypothesis. In many Medical Device Clinical Trials, the study hypothesis is developed in a way that specific outcomes are tested. The second important postulate of an innovative study design for Medical Device is inclusion of subsets. In many conditions it is seen that the study design exclude many subsets of the populations, which make the results differ from “real world” scenario. Instead, the predetermined subsets inclusion can give a study a wider acceptance and better power.
Genelife Clinical Research has capability and experience to submit IDE and 510K. Genelife Clinical Research has assisted clients with integrating the various medical device regulatory requirements into their quality management system such as ISO 13485, 21CFR820, Canadian Medical Devices Conformity Assessment (CMDCAS) and Medical Device Directive (MDD). This approach ensures that the quality management system is scalable and can serve the global needs for medical device market approval and distribution.