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.
Dermasun
Helios 2.0 - Innovative UVB-Light therapy system
The Dermasun 2.0 certified by Kiwa Dare
Dermasun has certified their new product, Helios 2.0 UVB-Light Therapy System, at Kiwa Dare. This certifications was done conform the Annex IV of the Medical directive Medical equipment 93/42EEG (MDD).
Dermasun Medical is an innovative and Dutch Company located in Amsterdam and is an official subsidiary of Sunshower B.V. Where Sunshower focuses on regular consumers, Dermasun specializes on developing and producing medical equipment of people with Psoriasis, Eczema or sun-allergies. Dermasun Medical was created in 2010 by two engineers from Delft, Merijn Wegdam and Oscar Meijer after they first created Sunshower in 2003.
Dermasun Helios
The Helios 2.0 by Dermasun is a compact unit which is easily placed within a corner of your shower. The complete system is made water proof so it is designed to turn on when you shower. The Helios is build in such a manner that the complete body is lit by the light coming from the device. The Helios is able to be configured by a timer but also the intensity of the light is adjustable.This is essential for the type of ailment the user is experiencing and is particularly important for people with sun-allergies.
Vision of Dermasun
The sun shines at the earth and makes life possible and is essential to live a healthy life. Sunlight on the skin is converted in the body to make Vitamin D. This is important for people to stay healthy but it also has the healing or suppressive powers against afflictions such as Psoriasis, Eczema and sun-allergies. It is the ultra Violette (UV) light and even more specific the UVB-radiation with which these ailments can be treated. the innovative idea of Dermasun Meidcal is to combine treatment of the Helios 2.0 with daily routine. Most people shower daily and this is the optimal time to shine some light on the body.
Medical Tool
Classification rule 9 - Therapeutic tool meant to exchange energy. This Medical apparatus is classified as a Class IIa. This Means that there are two manners of classifying the Helios 2.0 the first is by ISO/IEC 13485. The second manner is by conform Annex IV of the MDD.
Challenges
When certifiing medical equipment one is challenge with a tough process. next to the fact that all product which are active, read electrical, need to comply to the EMC and Product safety demands, the MDD has some additional requirements which need to be met. For instance there needs to be a clinical study in which the product is extensively tested if it produces the claimed and desired result. Apart from the desired result all or any side effects of the product are also tested. Even after the product is sold on the markt the supplier has to take note, documentation and has to act on all incidents on the use of the product in practice.
Kiwa Dare
Our mission is' to create a safe and interference-free World' we support our clients by developing safe an interference free products by research, EMC testing, and product safety testing. Finally when all is in order we certify the product so they can officially enter the trading market! since 2015 Kiwa Dare has been appointed by the ministry of peoples health and sport (Ministerie van Volksgezondheid, welzijn en Sport (VWS) for Annex III & Annex IV of the MDD for active Medical equipment.
The Kiwa Dare MDD Experience
'DARE!! Medical Certifications is a trustworthy partner when it comes to medical certifications. What you are looking for in a partner is one that thinks in your interests and helps you the best they can. This is what Kiwa Dare offers! All the final Reports are in order and complete, we give Kiwa Dare in general quality and service a 9/10'
Merijn Wegdam
Directeur Dermasun Medical