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Intended purpose - the cornerstone of medical device regulation
Ever wondered what truly drives the regulatory pathway for a medical device? It all boils down to one crucial element: the intended purpose. We interviewed reg…
Navigating the evolving EU medical device regulations: Insights for MedTech innovato…
The medical device industry is undergoing significant transformation, particularly in the EU, with the introduction of Medical Device Regulation (MDR) and In V…
Simplifying Medical Device Regulations: The Power of Partnership Between SimpliMedic…
SimpliMedica and RegMetrics are working together to create a seamless regulation journey for those who are developing a medical device. Adnan Ashfaq is the fou…
How can we ensure Regulators and Innovators speak the same language?
We recently invited regulators, funders, tech transfer officers, academics and startup founders to discuss the challenges of understanding and implementing Med…
Device classification - The first step of your regulatory strategy
If you are developing a device, you may find yourself wondering, how do I know if it is a medical device? If you are unsure, use the RegMetrics software and se…