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This blog post has been created for those who want to learn about the importance of CE Marking. We used Read More
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All the scientific articles are gathered together as a primary part of the clinical evaluation. MEDDEV 2.7/1 is the most Read More
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Absorbable & Non Absorbable Surgical Suture 510k * In general, clinical studies will not be needed for most surgical suture Read More
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What is the FDA Registration number?FDA Registration number provided by FDA soon after the confirmation of registration. This is applicable Read More
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The person responsible for regulatory compliance (PRRC) is not intended to take the place of a European Authorized Representative (EC Read More
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Device name: Peripheral Vascular Catheters MDR 2017/745: Class: Class III, Rule 8: Implantable device and long term surgical invasive device Read More
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The animal testing utilized for the assessment of the medical devices initial evidence of device safety, their potential performance when Read More
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Clinical Information system means all data, reports, writings, research, and calculations performed using a medical device in scope. Output is Read More
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UKCA Mark or a CE Mark logo is a must depending on which legislation the device has been certified under. Read More