News title: RegMetrics makes medical device regulatory compliance faster and easier

Link to news article: https://www.healthcarenewschannel.com/post/reg-metrics-makes-the-compliance-to-medical-device-regulations-quicker-and-easier

How can RegMetics help you?

RegMetrics supports you step by step with the legal requirements. No prior knowledge of regulations 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 regulations do I have to comply with? What standards can support my regulatory journey? Are there accredited testing houses that can help me test my product?

The need

Compliance with medical device regulations is essential for any MedTech company marketing medical devices. Currently, one of the key challenges 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 costs for regulatory support very high. Our own research has shown that innovators also struggle with the language of the regulations, finding the right supporting documents and knowing what to do next.

The solution

To help as many innovators as possible, we have developed the digital tool RegMetrics. The tool is designed to be easy to use and reliable. RegMetrics is a software that provides personalized regulatory support to MedTech innovators, with no prior knowledge required. The software guides innovators step by step through the legal requirements, breaks through long workflows and sets expectations for what lies ahead. It offers an objective and reliable approach where all content refers to official documents, while 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 University of Oxford's Natural Interaction Lab (NIL) to address a need identified within the innovator community.

RegMetrics was founded in 2021 after receiving funding from Innovate UK.

CEO/co-founder: Dr. Rita Hendricusdottir

'I think it is very important to ensure that patients have access to the latest technologies that can improve their lives. However, our research found that understanding and navigating medical device regulations is a barrier for many innovators. It can be a real struggle and often determines whether the technology reaches the market or not. The challenge is to bridge the knowledge gap between technology and law. I have always been fascinated by how to best connect disciplines to generate the strongest results. RegMetrics was built by innovators for innovators. With a bottom-up approach we can ensure that medical device regulations are accessible to everyone.'

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

Please take the opportunity to connect and share this video with your friends and family if you find it helpful.