Technical FileThe technical file for medical devices refers to all the documents that a medical device manufacturer has to submit to NB or CA for review & approval for CE certification.
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Clinical EvaluationClinical evaluation enables manufacturers to provide sufficient clinical evidence for demonstration of conformity of the device 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 medical devices in Europe.
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EUDAMED RegistrationEuropean Database on Medical 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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Medical Device TestingMedical device testing indicates that a Medical device is certified to perform as per intended use. The medical device testing provides evidence of its compliance with standards and regulations around the globe.
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Medical device 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 medical devices.
Read MoreMedical Device CE Marking Service covering reusable medical devices, equipment, disposables, implants, drug-device combination products, and home healthcare devices across all classes spanning a diverse range of indications.
