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Introduction
Jute Medical was established in 2020 with the aim of helping medical device manufacturers meet the expanded post market surveillance requirements as defined in Regulation (EU) 2017/745.
Based in the UK with technical experience in medical device analysis and the post market surveillance process we are able and happy to help.
Services
Who needs our services?
If you are a medical device manufacturer and have or plan to have devices on the market, you can benefit from our services!
Occasionally, there will be need to perform physical analysis and generate reports on devices which are thought to have been involved in incidents.
As outlined in (EU) 2017/745:
- Clinical evaluation and clinical investigations. Chapter VI
- Post-market surveillance, vigilance and market surveillance. Chapter VII
This is where Jute medical can help.
Given these obligations, you can benefit from our services if:
- Your organisation needs to bolster or reinforce its post market surveillance processes?
- Your organisation is new to the world of medical device manufacturing and needs some help in setting up and running the post market surveillance system.
- Your organisation feels it needs to free up its valued technical staff in order to shift focus within the organisation, saving time, money and increasing productivity.
- Your organisation needs someone within the UK to perform these tasks for you.
Post market surveillance services
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 analysing 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.