Medical Device Clinical Trial And Management

Do you know what Ethics Committee and Competent Authority approvals your study will require?

We support you in designing your clinical study with appropriate study endpoints, help determine the optimal sample size, study and drafting the study report per the required template and content.

What is the definition of medical device?

Medical device means any instrument, apparatus, appliance, software, implant, reagent, material or other article intendedby the

manufacturer to be used, alone or in combination, for human beings for one or more of the following specificmedical purposes:

• diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease

• diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,

• investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,

• providing information by means of in vitro examination of specimens derived from the human body, including organ,blood,

• and tissue donations, and which does not achieve its principal intended action by pharmacological, immunological or

• metabolic means, in or on the human body, but which may be assisted in its function by such means,

• devices for the control or support of conception, software shall also be deemed to be an active device.

Medical devices are products or equipment intended for a medical purpose. They must undergo a conformity assessment to demonstrate they meet legal requirements to ensure they are safe and perform as intended.

Manufacturers can place a CE (Conformité Européenne) mark on a medical device once it has passed a conformity assessment.

The conformity assessment usually involves an audit of the manufacturer’s quality system and, depending on the type of

device, a review of technical documentation from the manufacturer on the safety and performance of the device.