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Posted by JCR Desert Safari Jaisalmer on April 25, 2024 at 3:59am 0 Comments 0 Likes
In the realm of design and construction, every project is unique, demanding solutions that are not only functional but also aesthetically pleasing. Whether it's an architectural endeavor, interior design project, or furniture creation, the choice of materials plays a pivotal role in achieving desired outcomes. Among these materials, laminates stand out as versatile, durable, and customizable options that can elevate any project to new heights of sophistication…
ContinuePosted by LocalSkill on April 25, 2024 at 3:59am 0 Comments 0 Likes
In the digital age, the reputation of a company online can significantly influence its ability to attract top talent, especially for IT companies engaged in high-volume hiring. Glassdoor, a platform where employees and former employees anonymously review companies, has
become a critical touchpoint in the recruitment process. For IT staffing
services, understanding and managing the impact of these…
Posted by JCR Desert Safari Jaisalmer on April 25, 2024 at 3:57am 0 Comments 0 Likes
In the realm of interior design, few materials possess the versatility, durability, and aesthetic appeal quite like laminate sheets. From sleek modern designs to timeless classics, laminate sheets have become a staple in crafting stunning surfaces that exude both style and functionality. At Plymartcoin, we take pride in offering a diverse and exquisite laminate sheet collection that caters to the varied tastes and preferences of our esteemed clientele. …
ContinuePosted by Micheal Jorden on April 25, 2024 at 3:57am 0 Comments 0 Likes
The technical file is a collection of information and documents that describe in detail the medical device under consideration and in particular the aspects related to the safety and efficacy of the product, starting from the design phase up to post-marketing surveillance.
The technical file also describes all the possible solutions taken by the manufacturer to ensure maximum safety of the device.
This document must always be updated and, with the exception of class I DMs, IVDs included in Annex II and self-diagnostics, subjected to evaluation by a Notified Body in order to obtain the CE marking, a fundamental requirement for the marketing of DMs. in the European market.
Once the medical device has been placed on the market, the competent national authorities have the right to view the technical file, regardless of the classification of the DM, at any time.
Furthermore, an incomplete or inadequate technical dossier could lead to delays in market entry or a ban on the release of the product.
Regulatory Affairs supports many Italian and international companies in the certification process aimed at obtaining the CE marking. In particular, in order to obtain the CE marking, it deals with the creation of the technical file and all the activities connected to it:
We Support the manufacturer in collecting and producing the necessary documentation
Maintain relations with the analysis laboratories, with the Notified Bodies and with any production workshops
Review all existing documentation to support compliance with the applicable essential requirements of the Directive
Visit our website for more information about us and our various regulatory services.
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