Helping you navigate the world of medical device regulation
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How RegMetrics can help you
RegMetrics helps you navigate the world of medical device regulation.

Classify your medical device efficiently

Identify your safety and performance requirements

Retrieve your specific standards and relevant test houses
RegMetrics will provide you with suggested standards specific for your device and test centres that can help you test your devices according to the requirements
Hear it from our users
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.
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.
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 feel I understand it much better
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NEWS: RegMetrics receives the MPLS award
Great news! RegMetrics has received the MPLS commercial impact award from the University of Oxford.

What are the new device classifications in the In vitro Diagnostic Regulation (IVDR)?
Following a series of scandals, most notably regarding the Poly Implant Prosthesis (PIP) Breast Implant there was a major overhaul of European medical device regulation …

What is the difference between IVDR Class D and C?
This blog post will discuss ways in which high personal and public health risks for In Vitro Diagnostics (IVD) devices are determined – and introduce some of the classif…