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
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The first step in the regulatory pathway for any organisation is to identify the relevant regulation. Within the medical device industry, the most important distinction …
What are the new device classifications in the In vitro Diagnostic Regulation (IVDR)?
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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…