CLINICAL TRIAL

Clinical Research refers to any kind of scientific research conducted on volunteer individuals or materials obtained from them.

What are the Studies Conducted with Medical Devices?

According to Article 4 of the Regulation on Clinical Investigations of Medical Devices published in the Official Gazette dated 06.09.2014 and numbered 29111, Clinical Investigation of Medical Devices is defined as “systematic research or studies conducted on volunteers to evaluate the safety, efficacy, or performance of a medical device” in paragraph (r).

Clinical investigations are conducted for all medical devices, whether they have obtained the CE mark or not. They are divided into two categories: academic and commercial. Clinical research can be retrospective (looking back) or prospective (looking forward).

A successful research begins with successful planning. Contact us for end-to-end service from the planning stage to the completion of the clinical research.