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RegMetrics makes the compliance to medical device regulations quicker and easier.

How can RegMetics help you?

RegMetrics supports you with the regulatory requirements step by step. No prior regulatory knowledge is required. Currently the software helps you with the following questions.

Is my device a medical device? What is the classification of my device? Which part of the regulation do I need to adhere to? Which standards can support my regulatory journey? Are there Accredited test houses that can help me test my product?

The need

Complying to the medical device regulations is essential for every MedTech company bringing medical device to the market. Currently, one of the key challenge for MedTech companies is access to regulatory expertise as highlighted in the UKRI report: The state of EU Medical Device Regulation readiness in UK SMEs, 2020. In addition, the cost for regulatory support is very high. Our own research showed that innovators also struggle with the regulatory language, finding the right supporting documents and knowing what to do next.

The solution

We developed the digital tool RegMetrics in order to help as many innovators as possible. The tool is developed to be easy to use and trustworthy. RegMetrics is a software that provides personalised regulatory support to MedTech innovators, where no prior knowledge is required. The software guides innovators through the regulatory requirements step by step, breaks up long workflows and sets expectations for what’s ahead. It provides an objective and trustworthy approach with all its content referencing official documents, whilst using data driven technologies to cater to all types of medical devices from software to hardware as well as in-vitro diagnostics.

The technology was initially developed by the Natural Interaction Lab (NIL) at the University of Oxford, as a solution for a need that was observed within the community of innovators.

RegMetrics was founded in 2021 after receiving Innovate UK funding.

CEO / Co-founder: Dr Rita Hendricusdottir

'I am very passionate about making sure that patients have access to the latest technologies that can improve their life. However, our research has shown that understanding and navigating the medical device regulations is a barrier for many innovators. It can be a real struggle and often is a key determinant of whether the technology reaches the market or not. The challenge is to bridge the knowledge gap between engineering and law. I have always been fascinated in how to best connect disciplines in order to generate the strongest outcomes. RegMetrics is build by innovators for innovators, with a bottom up approach we can ensure medical device regulations is accessible to everyone.'

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#regulations #mdr #ivdr #medtech #healthtech #universities #sme

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