Reg Metrics Ltd

RegMetrics is a platform that simplifies medical device regulation by guiding users through EU MDR and IVDR compliance to help obtain CE marking and access UK and European markets. The company offers software tools, expert consultancy, and training to assist innovators, academics, and startups in navigating the regulatory process without prior knowledge.

The service is designed for visionaries and academics who need help navigating complex medical device regulations, such as determining if a product is a medical device, its class, and applicable rules. It targets those looking to de-risk development and accelerate market entry into Europe and the UK.

Users can start their journey for free by answering a short set of yes-or-no questions to determine if their product is a medical device. The first step is completely free, and the process continues with straightforward questions about the device's intended use to determine its class.

The platform provides a formal PDF for regulators and an interactive report for internal discussion after classifying a device. It also generates a comprehensive GSPR checklist and recommends standards and testing houses in the UK.

Pricing includes a free plan for basic features, a Premium plan at €199 per month or €2,000 per year with a 16% discount for annual payment, and an Enterprise plan for unlimited projects and wide access.

The software is built by academics for academics and includes features like device classification, GSPR checklists, and standards recommendations. It also offers consultancy and training courses led by experts who understand academic challenges.

The company was founded while working at the University of Oxford and is funded by EPSRC, EIT Health, and Innovate UK. The team includes CEO Rita Hendricusdottir, CSO Jeroen Bergmann, and regulatory experts like Faiza Jabeen and Steve Lee.

RegMetrics is located at 7 Bell Yard London WC2A 2JR and can be contacted via the business phone number 07804 610517. The address places the company in central London, England.

The platform supports both EU MDR and IVDR devices and helps users comply with legal requirements referenced from official sources like eur-lex.europa.eu. It covers the European and UK medical markets.

The software is described as easy-to-use with straightforward yes-or-no answers and tickboxes, requiring no prior regulatory knowledge. It translates legal requirements into simple questions to help users quickly figure out compliance needs.

The company offers interactive training sessions and practical consultancy to help users master complex regulations and gain confidence in advancing device development. These services are aimed at saving time and administrative overhead for researchers.

The platform helps users identify testing houses in the UK and provides a customised sequence of topics based on the device class and previous answers. It aligns testing protocols with identified standards to position devices well for approval.

The service is particularly noted for its ability to help universities save research costs and reduce administrative overhead for translational researchers. It is trusted by academics and support staff at leading institutions around the UK.

The company allows users to switch and cancel their plan at any time, offering flexibility in subscription management. This applies to both monthly and annual billing cycles.

The platform provides a first step to determine if a product is a medical device, which is free, followed by device classification and GSPR checklist generation. These steps are essential for understanding the risk to patients and influencing safety requirements.