CE for In Vitro Diagnostic Device

CE for In Vitro Diagnostic Device

We deal with the aspects of professional Consulting for medical devices

We Are A Premium Regulatory Compliance Solutions Provider For Medical Devices/IVDs

Technical File

The 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 Evaluation

Performance 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 Surveillance

Post-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 Representative

Non-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 Registration

European 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 Labelling

The 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 Testing

Performance 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 System

It 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.

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One-Stop Solution for IVD CE Marking

Our 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.

Solution for IVD CE Marking

CE Marking Consultants

We have a team 20+ talented, skilled & experienced technical consultants. Our CE marking consultants help the manufacturers to place their IVD medical devices on European Market.

Document Control

We take care extra care to maintain control over documentation and client confidentiality which creates value and helps us maintain client’s best interests.

Annual Maintenance

Our Regulatory consultancy provides customizable services to update and maintain your regulatory framework and QMS and complying with the needs of various regulations.

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