The issue of product safety is now a priority for every manufacturer, as is the importance of knowledge of legislation and regulations to ensure the ultimate goal of 'preventive protection' for the consumer.
Thanks to Kiwa's expertise, medical device companies can demonstrate that they meet the essential requirements for medical devices and gain access to the European market, as well as obtaining prerequisites for access to other global markets. In addition, thanks to Kiwa Italia's technical expertise, medical device manufacturers can rely on a trusted partner that can guarantee the execution of an effective conformity assessment process, which can combine a guarantee of market protection with a business tool.
Our services in the field of product certification for medical devices
Medical devices manufactured or traded in the EU must comply with the Medical Device Regulation (EU) 2017/745 (MDR) and must be CE marked. Kiwa Cermet Italia and Kiwa Dare (based in The Netherlands) have been designated notified body for Regulation (EU) 2017/745 (MDR).Show
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.Show
Surgical face masks are primarily used to protect patients from contamination from health care providers. Because this often involves vulnerable people, it is vital that quality medical face masks are used. Kiwa tests surgical face masks according to the European standard EN 14683.Show