CE Mark for Medical Device

CE Mark for Medical Device

We deal with the aspects of professional CE Marking Consultancy for medical devices

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

Technical File

The 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 Evaluation

Clinical 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 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 medical devices in Europe.

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Medical Device CE Marking

EUDAMED Registration

European 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 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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Medical Device Testing

Medical 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 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 medical devices.

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One-Stop Solution for Medical Device CE Marking

Medical 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.

Solution for Medical Device 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 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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