Processing of the Technical Dossier and CE marking of medical devices

::: Services - Medical devices - Technical Dossier and CE marking of medical devices :::

From the Technical Pharmaceutical Consulting we advise and we covered your needs in:

Preparation and / or revision of the Technical Dossier of medical devices.
Advice and preparation of documentation necessary for obtaining the CE Quality Mark.
Search and selection of a Notified Organism.

All devices must be supported by the market a Declaration of Compliance to ensure that it meets the essential requirements laid down by health regulations.
This Declaration of Conformity with the kind of device, it can be done by an outside agency (notified body), or by the manufacturer.
In the case of the notified body that, before issuing the Declaration of Conformity, will evaluate all documents making up the product's Technical Dossier (Technical File), and whether it is complete and meets the requirements, issued the Declaration of Conformity or CE marking (EC Certificate) pursuant to Directive 93/42/EC.
If the Declaration of Conformity is undertaken by the manufacturer (product class I non-sterile and without measuring function, and devices), although no Notified Body will assess the technical dossier, it must also provide this dossier, because it combines documentation demonstrating compliance with the essential requirements that are mandatory for any medical device market.
The technical dossier includes data from the main device, its manufacture, design, efficiency, safety, risk analysis, etc.