DEKRA Certification B.V, business line Medical together with KEMA Quality as one integrated Notified Body under DEKRA ownership became one of the five largest European Notified Bodies in the world, with a broad scope including all active and non-active medical devices, active implants, in-vitro diagnostic devices, drug/device combination products, devices incorporating animal tissue and devices incorporating human blood. In addition, DEKRA/KEMA Notified Body is a service provider for access to market for all major markets around the world.

With full operational offices in California, Pennsylvania, Israel and the Netherlands, DEKRA/KEMA Notified Body is considered a benchmark in the medical industry. DEKRA/KEMA Notified Body is known for its outstanding international reputation as a certifier.

The CE mark symbol on your product enables you to trade freely within the European Union. However, with this privilege come obligations. By affixing the CE Mark to your product, you are indicating your adherence to procedure compliance regarding in accordance to the relevant European Directives. In other words, you are responsible for the consequences of the use of your product. But how can you be certain that your product is in compliance with these Directives?

DEKRA/KEMA Notified Body expertise enables it to determine whether your product is in compliance according to the criteria of standards and European Directives. For most medical devices, this is mandatory. DEKRA/KEMA Notified Body can perform all voluntary and obligatory tests and reviews of your product and organization. As a Notified Body, DEKRA /KEMA combines both the product testing and the system certification in a single audit, thereby saving you time and money!

In order to prepare for Notified Body audits, prepare technical dossiers or 510(k) files, many companies obtain assistance from experienced Regulatory consultants. DEKRA/KEMA Notified Body only recommends consultants that have the experience and competence to prepare companies for successful audits and file submissions. MedicSense is one of the experienced consulting companies in the medical field that is well recommended by DEKRA/KEMA Notified Body. MedicSense’s years of experience in the field of medical devices compliance management - within both the EU and the FDA- combined with its knowledge and familiarity of the medical device industry enables it to provide flexible, customized services to its clients, thus guaranteeing their ability to take full advantage of all aspects of the European market.

for more in information please visit us at www.medical-device-certification.com