Kiwa Notified Body for Medical Devices
Kiwa is a Notified Body (NB) in the field of medical devices. We assess if medical devices with medium or high risk meet the legal requirements according to the MDD 93/42/EEC Directive. If the devices meet the requirements, they can be admitted to the European market and be CE marked. Within Kiwa, we have Kiwa Cermet in Italy and Kiwa Turkey who are active in the medical device field.
Kiwa has the ability to supply the tools for the conformity evaluation, according to what is set by the MDD and subsequent amendments or by optional technical regulations.
Kiwa Cermet Italia
Kiwa Cermet Italia is a Notified Body, authorized by the Italian Ministry of Health with the no. 0476, and has able to deliver services related to CE mark to a vide range of medical devices, including:
- non-active and non-implantable devices
- non-active implantable devices
- devices for the healing of injuries
- active, non-active and accessory dental devices
- devices for taking images and for monitoring physiological parameters
- devices for radio- and thermotherapy
- sterile medical devices
- particular devices referred to in the Machinery Directive 2006/42/CE
Kiwa Cermet Italia is also a Certification Body accredited by ACCREDIA, according to the scheme ISO 13485.
Kiwa Turkey provides worldwide conformity assessment services as Notified Body with NB number 1984. Kiwa Turkey is an Accredited Body by TURKAK for Management System Certification according to ISO 9001 and ISO 13485 standards.
More than twenty years of experience
Kiwa boasts a wide and in-depth experience as Notified Body from over 20 years in medical devices certification, with thousands of products already certified, providing all the necessary services to get complete answers and reliable information on medical devices certification services according to the MDD 93/42/EEC Directive and subsequent amendments.
Member of TEAM-NB
Kiwa Cermet Italia and Kiwa Turkey are members of TEAM-NB, the European Association Medical devices of Notified Bodies.