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.
Peercode
Software for eHealth and disease monitoring
The Kiwa Dare MDR Experience
Kiwa Dare excels in short communication lines, boasts experienced auditors and has relevant and justified rationales when providing audit findings. Peercode values Kiwa Dare highly for its professionalism, setting clear expectations and being a reliable and effective partner. We have full confidence in working with them for the years to come.
Govert de Vries, Director Peercode BV
About Peercode 
Peercode operates in the medical software market and works closely with Medical Centers (including VUMC, AMC, UMC Utrecht and Gelderse Vallei Hospital) and with international pharmaceutical companies. The Peercode software makes it possible to monitor disease stages and disease activity. This software can also set off triggers based on clinical input (eg BMI, heart rate, allergy symptoms, blood values) and patient data (eg, questionnaires) that can warn both the patient and care provider that, for example, further investigation is needed. Peercode has its own team of Medical Device and Regulatory Affairs Experts who work for both Peercode and external clients (pharmacists, hospitals and (software) medical device manufacturers).
Certification
Kiwa Dare Certifications recently assessed two of Peercode's software products for compliance with the new European Medical Devices (MDR) regulations. Our software solutions were previously registered as Class I devices but under the new regulations they were eligible for a higher risk rating (IIa). Both software products have been successfully certified as Class IIa Medical Device, whereby Peercode fulfills the role of Legal Manufacturer for its clients (pharmacists and hospitals).
The collaboration with Kiwa Dare
Prior to the product certification, we asked Kiwa Dare to reassess our already certified quality system in accordance with ISO 13485 and the new process requirements of the MDR. The availability of Kiwa Dare, their specific high-quality knowledge in the field of software and their short communication lines were reasons to switch to a notified body (Notified Body) that was new to us. We are very satisfied with our choice and the experience so far with Kiwa Dare. It was important for us to experience that the transition from DARE!! to Kiwa Dare, has not influenced the timelines or expectations during our assessment process. We have experienced to date that, just like Peercode, they put the customer first,
The Kiwa Dare MDR Experience
Kiwa Dare excels in short communication lines, boasts experienced auditors and has relevant and justified rationales when providing audit findings. Peercode values Kiwa Dare highly for its professionalism, setting clear expectations and being a reliable and effective partner. We have full confidence in working with them for the years to come.
Govert de Vries
Director Peercode BV