Resources

Get the latest white papers, process charts, and other resources about medical device regulatory affairs, quality assurance, human factors, and cybersecurity requirements.

Download the free chart: Colombia Regulatory Approval Process for Medical Devices
Colombia INVIMA Medical Device Regulatory Approval Process
To market a medical device or IVD, manufacturers must register with the National Food and Drug Surveillance Institute (INVIMA), the country’s medical
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Download the Chart on the Medical Device Approval Process in Costa Rica
Costa Rica medical device & IVD approval process
Medical device manufacturers who want to enter the Costa Rican market need to obtain approval from the Costa Rican Ministry of Health. There are a
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Download the Chart on the Medical Device Approval Process in Europe
Europe CE Marking Regulatory Process for Medical Devices
In order to commercialize medical devices in the European Union , a CE Mark certificate is needed. This certification verifies that a device meets
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Download the Chart on the IVD Approval Process in Europe
European IVD Regulatory Approval Process
IVD devices (In Vitro Diagnostics) are a subset of medical devices primarily used for to testing human fluids such as blood, tissue or urine in a
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This chart illustrates CE Marking for medical devices under Europe's MDR.
Europe Medical Devices Regulation (MDR) CE Marking Regulatory Process
In order to commercialize medical devices in the European Union , a CE Mark certificate is needed. This certification verifies that a device meets
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