CRO
We assist you with managing your clinical trials
Our Contract Research Organization (CRO) services ensure comprehensive and efficient management of your clinical trials.
Clinical evaluation is the final validation of a medical device to confirm that it functions as intended and can be used safely by patients according to its instructions for use.
To fully comply with MDR 2017/745 and IVDR 2017/746 regulations, it is important to follow the requirements defined in ISO 20916:2019 for in vitro diagnostic devices and ISO 14155 for medical devices.
It primarily focuses on clinical research services, clinical trial data management including statistical analysis, and all necessary data to demonstrate device safety.
Manufacturers based outside the European Union planning to enter the European market must conduct clinical trials in Europe in compliance with the new MDR 2017/745 and IVDR 2017/746 regulations.
CMC has been working in the field of medical devices and IVDs for a decade; our team has over 15 years of experience; we specialize in regulatory compliance; and we can help you meet all European requirements for your clinical evaluation performance study.
We offer a wide range of professional services to assist medical device companies in launching new devices to market.
CMC can design clinical studies that comply with standards for manufacturers based on the most comprehensive regulatory guidance documents.
The current clinical guidance documents in the EU region are as follows:
Representation Service
CMC can also be your legal representative in the EU for clinical trials of medical devices and/or in vitro diagnostic devices.
