Simplifying Market Access: i3CGLOBAL European Authorized Representative Services
Introduction
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Introduction
I3CGLOBAL: Pioneering Excellence in Medical Device Regulatory Consulting
Introduction:
EU Declaration of Conformity
The EU declaration of conformity must be drawn up before being placed on the market by the manufacturer or its authorized representative and guarantees its compliance with the essential requirements established by European Authorized Representative regulations.
The declaration of conformity must be completed for each product model and must include the following elements:
FDA Registration
A drug broadly speaking, is any substance that when administered into the body either Internal or external for treatment, mitigation or prevention of any disease or disorder in a living organism which can alters normal bodily function.
There is no single, precise definition, as there are different meanings in drug control law, government regulations, medicine, and colloquial usage.
Clinical Evaluation Report
Today we’ll cover some of the more critical aspects of clinical evaluation reports.
What Should You Know About The Medical Devices?
Every month, there are a lot of new medical devices which are submitted for the marketing approval from the FDA. One of them is the CE Marking approval which shows out the one device which will show the audience that it is purely legal and it is authorized for being a medical device. Most of these devices are firstly turned down or they are also re classified some of the times, but hundreds and thousands of them ended up in getting the approval for marketing it nationwide.
CE Mark Consultants
Due to the complexity of the medical device and various models makes the process of CE Marking more complicated. Highly reputed consulting team with experiences in CE certification of medical device only can successfully guide you through the entire process.
Below mentioned are the major reasons why a experienced technical consultant is recommended for Medical Device CE mark Consultation and Certification.
FDA 510(k)Consulting
I3CGlobal is the ONLY consulting company who takes up complete turnkey FDA 510(k) projects. We cover any type of medical devices anywhere in the world FDA 510k .
Special features of I3CGlobal
Technical Documentation
The Technical Documentation must prove that the product fulfils the requirements laid down in the Medical Devices Directive 93/42/EEC. The Technical File for medical devices should take account of the following aspects:
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