Although the requirements for clinical evaluation are general for all devices, each device is unique and requires a tailored approach to its clinical evaluation.
Our medical device team is ready to provide you with the following services:
We handle clinical evaluation of medical devices in multiple ways
What can we do for you?
Our expertise
Approach
Firstly, we will thoroughly study your product, focusing on identifying its key characteristics such as intended purpose, intended user, indications, and clinical benefits.
Secondly, we will determine all relevant standards and guidelines applicable to your product.
Based on these key characteristics and applicable standards, we will define the clinical strategy and proceed with the clinical evaluation plan and report.
It is important to note that our medical device team can be involved at any stage of the device lifecycle. We can start the clinical evaluation early to provide input for device development and certification or assist with ongoing clinical evaluation for devices already on the market, as the MDR requires.
Team
Diverse Team: Clinical evaluation is an independent process but is strongly interconnected with other processes like device development, risk management, and post-market surveillance. Our medical device team possesses extensive cumulative expertise to offer a comprehensive approach.
Comprehensive Coverage: Our medical device team has the experience to conduct clinical evaluations for a wide range of devices, from risk class I to III, including active and implantable medical devices, as well as software as a medical device.
