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.
Nemo Healthcare
A beating heart
Experience Nemo Healthcare
Kiwa Dare measures customer satisfaction after every project. We are proud that Nemo Healthcare has rated our services with an average of 8.2 out of 10.
A beating heart
Recently DARE!! Medical Certifications has conducted a product safety investigation on the wireless Fetal monitor developed by Nemo Healthcare; an innovative medical product with which the unborn child can be monitored in a mother- and child-friendly way.
Nemo Healthcare
The company was founded in 2010 as a result of a joint research project of the Máxima Medical Center and Eindhoven University of Technology (TU/e). Nemo focuses on improving the monitoring of the unborn child.
Electrophysiological signals are used so that it’s not necessary to enter the body.
The Nemo Fetal Monitoring System
Kiwa Dare has examined the wireless monitoring system, which is used before and during childbirth. The monitoring system uses six electrodes to pick up both the heartbeat of the mother and that of the unborn child. In addition, the system measures the contractions of the mother's abdomen. The Nemo Fetal Monitoring System is used in the hospital.
Clinical data
The Kiwa Dare research is part of a larger project in which Nemo Healthcare wants to have the product certified in accordance with Annex III (type approval) of the Medical Devices Directive. However, this requires sufficient clinical data first. To be able to collect these, the system is used in a controlled medical environment. A clinical research project has been set up for this purpose, which has been approved by the Medical Research Ethics Committee NedMec.
Project
For Kiwa Dare this was a fascinating project. Nemo Healthcare was an enthusiastic and knowledgeable customer and had thoroughly prepared the investigation.
EN60601 examination
The standard that has been applied concerns the EN60601 which has been specifically developed for medical devices.
Experience Nemo Healthcare
Kiwa Dare measures customer satisfaction after every project. We are proud that Nemo Healthcare has rated our services with an average of 8.2 out of 10.