Service – Electronics and Automation
CE marking for medical devices
The aim of this service is to carry out all the activities necessary for a product (bed, relax chair, bed base, etc.) to be labelled as a Medical Device in accordance with Regulation (EU) 2017/745.
The necessary activities include:
-Preparation of the technical dossier.
– Risk analysis in accordance with ISO 14971:2019.
-Clinical evaluation of the product.
-Development of technical product documentation.
-Laboratory tests (mechanical and electrical) to accredit compliance with the requirements.
– Management of the compulsory health licence as manufacturer/importer.
-Registration of products on the corresponding platforms.
1
What problem will it solve?
It allows products to be placed on the market with the CE health mark as a symbol of product safety.
2
What competitive advantage will the company gain?
Technical product documentation, laboratory test certificates, licensing and CE marking.
3
What will be delivered to the client?
Technical product documentation, laboratory test certificates, registration as a medical device manufacturer, registration of medical devices on national and European platforms.
Questions about this service?
Very fast, professional and friendly service and treatment. Totally recommendable.
Pascual Ortega
