Overview

Jute medical aims to help medical device manufacturers meet the expanded Post market surveillance and vigilance requirements as defined in (EU) 2017/745: -Clinical evaluation and clinical investigations. Chapter VI -Post-market surveillance, vigilance and market surveillance. Chapter VII What we do. -Jute medical is able to perform technical post-use analyses, organize logistics, perform sterilization services required for international shipping. The potential benefits of using Jute medical, Perhaps: -Your organization needs to bolster or reinforce its post market surveillance processes? -Your organization is new to the world of medical device manufacturing and needs some help in setting up and running the post market surveillance system? -Your organization feels it needs to free up its valued technical staff in order to shift focus within the organization, saving time, money and increasing productivity? -Your organization needs someone within the UK to perform these tasks for you? Jute medical can strengthen your post market surveillance services and enhance the feedback from your product in the market. The benefits of which include: -Gathering safety and performance data of the device throughout its expected lifetime -Identifying previously unknown side-effects and monitoring the identified side-effects and contraindications. -Identifying and analyzing emergent risks on the basis of factual evidence. -Ensuring the continued acceptability of the benefit-risk ratio -Identifying possible systematic misuse or off-label use of the device, with a view to verifying that the intended use is correct. -Very quick responsiveness and reporting for severe adverse event cases. Contact us or visit our website for more information.