We provide comprehensive clinical evaluation services for medical devices, ensuring compliance with the Medical Device Regulation (MDR) 2017/745 in Europe.
We assist in drafting the Summary of Safety and Clinical Performance (SSCP), mandatory for implantable and class III devices. This document undergoes validation by a Notified Body and is publicly available via Eudamed, providing crucial information for healthcare professionals and patients
With our service, you can confidently navigate the complex regulatory landscape, ensuring your medical device meets the highest standards of safety and efficacy.
Clinical evaluation is a key requirement under the European Medical Device Regulation (MDR). Failure to conduct a thorough clinical evaluation could lead to non-compliance, resulting in penalties or withdrawal of the product from the market.
Through clinical evaluation, manufacturers can assess the safety and performance of their medical device. It’s crucial to ensure that the device performs as intended without causing any adverse effects, ensuring patient safety.
Clinical evaluation is the heart of a medical device. But it is often the most complex and resource intensive part. We find the most effective way and focus on what matters.