For Medical Devices, 13485, 14971, MDR 2017/745, Meddev Guidelines, MDCG documents, Clinical Evaluation and Clinical Studies etc. We provide training services on subjects. Quality Management Systems; We provide training services on ISO 9001, 13485, 27001, 14001, 45001, 22000, 16949, GMP.

With medical device CE certificate consultancy services, you are supported in the process of obtaining the certificate. One of the factors that ensures the compliance of medical medical devices with the necessary conditions and their use in the market with appropriate production in a way that does not pose a threat to human health and safety is the Medical Devices CE Certificate Management. In this context, companies that do not have a CE certificate cannot put any medical device on the market.
According to the medical device directive, the controls and tests applied should be determined according to the risk level of medical devices. Within the scope of this directive, necessary tests and controls are applied to products with high risk levels. Accordingly, the risk classes of medical devices are specified and a CE certificate is given to those who meet the conditions.

What is Medical Device CE Certificate?

The CE certificate, which is among the documents required for medical device production, is also required for sales. In order to determine and show that the manufactured medical devices meet the basic requirements, the devices must go through the conformity assessment methods. These methods differ according to the risk class with tests. CE certificate is given to medical devices whose conformity has passed the test, and CE marking is attached to the products. The responsibility for placing the CE mark on the product belongs to the manufacturer. 
The important thing here is that the sign is visible. In our country, there are companies that work to issue CE certificates to medical devices. By receiving consultancy services from these companies, manufacturers can obtain a CE certificate for the products they produce. CE certificate helps companies to have an advantage in their sales.

Why Get Medical Device CE Certificate Consultancy Services?

Medical device CE certification consultancy allows companies to obtain the best certification of medical devices produced. Compliance with all safety and performance requirements related to devices is checked and problems are fixed with professional consultants. In order to confirm the suitability of medical devices, the selected route is reviewed and the most efficient examination process is conducted within this route. 
Reliable inspection processes, on the other hand, allow creating confidence and reliability in CE marking project planning. The documents to be obtained are basically graded according to the risk classes, and CE certificate is given to these devices whose suitability has been tested. For this reason, you can benefit from medical device consultancy services by getting support during all these periods.