References Kiwa Dare
What others say about our products
Kiwa Dare has been designated by the Ministry of Health, Welfare and Sport as Notified Body, since the end of 2015. Medical Certifications tries to make sure that the medical devices are safe before they are being used in the health care sector. Before this is achieved a series of assessments, tests and measurements need to be completed.
The Medical Device Regulation applies to all medical devices and accessories which come with the medical device. Devices are split up in different risk classes which are assessed and tested according to the relevant requirements.
References
Kiwa Dare performs conformity assessments for compliance with the Medical Device Regulation and EN-ISO 13485 for manufacturers of active medical devices and software. These references can be found below.