Technical FileThe technical file for In-vitro diagnostic devices refers to all the documents that an IVD manufacturer has to submit to NB or CA for review & approval for CE certification.
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Performance EvaluationPerformance Evaluation enables manufacturers to provide sufficient scientific, clinical and analytical evidence for demonstration of conformity of the IVD with the general safety and performance requirements.
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Post Market SurveillancePost-market surveillance (PMS) is a system that provides continuous feedback about a device on the market in order to maintain a high standard of product quality.
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EU RepresentativeNon-European manufacturers need to appoint an authorized European representative in order to sell their In-Vitro Diagnostic devices in Europe.
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EUDAMED RegistrationEuropean Database on In-vitro Diagnostic Devices, is the IT system engineered by European Commission to put into effect Regulation (EU) 2017/745 on Medical Devices & Regulation (EU) 2017/746 on In-vitro Diagnostic Devices.
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UDI LabellingThe UDI is a series of alphanumeric characters which is designed to provide a globally accepted, single harmonized identification. It allows clear and distinct identification of a medical device.
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Performance TestingPerformance testing indicates that an IVD is certified to perform as per intended use. The performance testing provides evidence of its compliance with standards and regulations around the globe.
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Quality Management SystemIt is an organized system of processes encompassing all critical aspects of an organization that must be adhered to in the quest for designing, developing, and manufacturing an IVD medical device.
Read MoreOur In-vitro Diagnostic Device CE Marking Service covering General IVDs, Self-testing IVDs and all other classes of devices ensures that quality certification is provided to the manufacturer to legally sell their products in the European Union.
