Regulations made simple

RegMetrics guides you step-by-step through the regulatory journey, from classifying your medical device to complying with the right requirements.

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Medical device regulation is complex. With RegMetrics, we simplify your journey.

You've got a brilliant idea for making a difference in the medical world but don’t know where to start. We built RegMetrics for people like you — visionaries from all kinds of fields who could use help navigating the complex rules of medical device regulation.

Our easy-to-use tool will take you through the regulations step-by-step. By the end, you will be well-positioned to continue your application for a CE mark, offering access to both the European and UK medical markets.

No regulatory knowledge needed
Backed up by references to the legal documents
Straightforward yes-or-no answers and tickboxes
Built by academics, for academics
Includes both MDR and IVDR devices
Find out for free if your product is a medical device

RegMetrics guides you each step of the way

Check if you need to follow regulations

Your RegMetrics journey will start with a free, short set of yes-or-no questions that will tell you whether or not your product is a medical device. Only medical devices need to comply with medical device regulations.

This step is free!

Outcome

Your product’s status as a medical device or non-medical device

Get your device class

Next, you'll answer some straightforward questions about your device and what it's meant to do. RegMetrics will tell you what "class" your device is. This class indicates the risk to the patients. It will influence the requirements you need to meet to make sure your device is safe.

Outcome

Device classification as a formal PDF for regulators plus an interactive report for internal discussion

Identify your device requirements

Based on your device class and previous answers, we'll take you through a customised sequence of topics and ask you to choose any statements that apply to your device.

Outcome

A comprehensive set of requirements for your device known as the "GSPR check list"

Review your standards and get ready to test

Your device may have standards to conform with. These standards are aligned with the requirements you've already identified. If you base your testing protocol on the standards, your device will be well-positioned for approval. We'll help you identify testing houses where you can get your device tested.

Outcome

The first part of your technical documentation, ready to be submitted to your regulator

Start your journey

For education, simple regulatory support that’s a perfect fit for universities

Universities have a rich history of inspiring innovation. We are proud to be trusted by academics, support staff, and translational researchers at leading institutions around the UK. Save time, administrative overhead, and research costs.

Built by academics, for academics.

Learn more Contact us

Supercharge your competitive edge in R&D
Tap into RegMetrics' consultancy service
Upskill your regulatory knowledge
Make use of our expert training materials

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Hear from people who’ve been there

RegMetrics is helpful when scoping grant submission activities, de-risking the proposal and ensuring sufficient budgetary requirements. RegMetrics also helped us with our regulatory strategy and I would recommend using the tool.

Clark Crawford

West Midlands Academic Health Science Network, UK

I have spent thousands of dollars on regulatory advice and I did not understand any of it, just with this [training] session and using RegMetrics, I understand it much better.

MedTech innovator

RegMetrics is the only tool that tells you what class of medical device you are working on and why. The "why" is very helpful for founders, as it gives them confidence and insight into medical device classification.

Dr. Bodo Brückner

Life Science Accelerator Baden-Württemberg, Germany

I liked the examples used, they really helped me to understand when to answer yes and when to answer no to certain questions - particularly around the use case and intended purpose of the device.

Dr Laura Powell

Technology Transfer Associate at the University of Southampton

RegMetrics provides an excellent workflow to go through each of the parameters step-by-step. Very easy to follow the process.

Lecturer in Cyber Security

University of South Wales

RegMetrics presents so much complicated information in a really accessible way, the glossary of terms on each page and the examples for context for each question are super helpful. The fact the triaging system within the software takes you through question by question. The list of questions and answers at the end and the consequent incremental changes in classification are super helpful to see.

Dr Lisa McCann

Reader in Digital Health & Care at the University of Strathclyde

Get the latest on RegMetrics

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Navigating the evolving EU medical device regulations: Insights for MedTech innovators

Intended purpose - the cornerstone of medical device regulation

Frequently asked questions

Our tool provides device specific, step-by-step regulatory guidance for anyone developing a medical device they’d like to bring to market — no prior experience necessary. We’ve translated the legal text that underpins the regulations into easy-to-understand questions. As you progress through RegMetrics, we provide you with term definitions, context, and anything else you need to know right there.

We’ve divided the regulatory journey into stages. At the end of each stage, you’ll be able to access a PDF that you can add straight to your technical documentation. We’ll also provide you with a summary page at each stage. These pages contain all the information you’ve created so far. These summary pages are perfect for you to discuss with your team internally, share with your research support and tech transfer, or use as a support to write the regulatory section within your grant proposal.

We are always happy to help. Please contact us if you have any questions regarding the software.

We also offer consultancy services for academics and start-ups that would like personal, expert-led guidance throughout their regulatory journey. We have a passion for upskilling your regulatory knowledge, and we offer a interactive workshop designed to do so.

For institutions using RegMetrics at scale, we are pleased to offer training materials to help you “train the trainers” and meet your uptake targets.

Yes, RegMetrics provides consultancy services. We are specialised in supporting academics, Spin-out and Start-up companies that are developing medical devices / in vitro diagnostic medical devices with their regulatory journey. Get in contact with us and we are happy to help.

We’d like to hear from you

We’re all for ambitious goals, and here’s ours: to digitise the entire regulatory pathway. Right now we're well underway on the first stretch of that journey. As a platform in active development, we're committed to shaping the product and pricing packages toward your needs. If you have feedback or feature requests, we’d welcome your perspective.

Early access to AI support for registered users

We'll soon be adding AI support to RegMetrics. It can help you craft your device description and more. Follow us on LinkedIn for the latest news.

Get started for free

It’s free to check if your product is classified as a medical device. Continue on the journey through classification, requirements, and standards with a monthly subscription. Enterprise plans available.

Pricing plans Get started