Clinical trials of medical devices are special research involving people that is conducted to assess the functionality, efficiency and safety of the test articles.
The tests are held on special accredited bases. After the completion of clinical trials, the conclusion of an ethics committee, program, protocol and report are made.
Clinical trials can be initiated only after promising results in preclinical studies (studies on biological models and laboratory animals), as well as the approval of the ethics committee and the positive decision of the authorized body for testing.
The log and the act of informed consent of the patient are prepared before the start of clinical trials.
Informed consent is a process that allows a patient or a healthy volunteer to freely confirm their willingness to participate in clinical trials. Informed Consent Act is called the document, which is signed by the test participants (patient and physician-researcher). Physician-researcher informs the patient about all aspects of clinical trials, which may influence the decision to participate in the experiment (the benefits, risks, time costs, possible side effects and so on.). Therefore, this agreement is called Informed. Once a potential research participant is informed about all aspects of participation in clinical trial, the investigator provides patient with written information, which describes the details of the study (duration, procedures, risks and potential benefits, and so forth). Once again, having carefully studied the document, the participant decides either sign the agreement or not.
Test participant may withdraw from the study at any time without giving a reason.
If a manufacturer of medical products provides materials of the previously conducted clinical trials, then the specialized evaluation of materials of clinical trials is conducted. In this study, patients do not participate. Experts process the data provided by the manufacturer and make a report.
On the basis of documents obtained as a result of clinical trials or specialized evaluation of materials of clinical trials - the authorized conformity assessment body shall take a decision on the conformity of the medical device technical regulations or non-compliance.
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