Medical Devices in the UK

Thanks to Kiwa’s expertise, medical device companies can demonstrate that they meet the essential requirements for medical devices and gain access to the markets where they need to sell their devices.

Kiwa UK (Medical Devices) will be able to offer ISO 13485 under UKAS later this year and is under application for UKCA for medical devices. This will ensure that along with the other Kiwa companies, our customers will have access to key global markets.

Please use this page to find out more about our Medical Devices offerings and contact with any queries relating to ISO 13485 certificate services.

Enquiry Form

Do you wish to transfer your current ISO 13485 certification?

Are you seeking your first ISO 13485 certification?

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How would you rate the Risk level of your devices & operation?

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What is the total number of Full Time Equivalent (FTE) Employees?

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Who are we?

Kiwa was Founded in 1948 in the Netherlands, initially to monitor the quality of drinking water. Kiwa NV is a European institution for testing, inspection, and certification (TIC), headquartered in Rijswijk in the Netherlands. The institution is highly active in over fifty countries worldwide. Kiwa participates in the safety analysis of many new European and international technologies, as well as the drafting of safety standards for numerous devices and components. Kiwa provides safety-related certification, testing, inspection, auditing, advising, and training services to a wide range of clients, including manufacturers, policymakers, regulators, service companies and consumers. Kiwa employs over 10,000 people in over 40 countries, in Europe, Asia, the Americas and Oceania. Since 2021 we are a member of SHV Family of Companies.

Kiwa Cermet Italia S.p.a has been a Notified Body for more than 20 years and has been MDR designated since July 2021. They have a broad scope and are very well recognised and respected in Italy and Europe.  They also offer ISO 13485 under ACCREDIA.

Kiwa DARE joined the group in March 2021 and are designated for MDR, mainly for active devices. They also offer ISO 13485 and are accredited for testing in accordance with the standard for medical equipment, EN-IEC 60601, for both EMC and safety aspects.

Kiwa Turkey are a Notified Body under MDD and will merge into Cermet, in terms of resource and client MDR certificates which will be under Kiwa Cermet for approval.

With the addition of our UK business, which will offer 13485 and UK CA, we will have a well-rounded offering for this sector. We are also looking to add MDSAP to our portfolio as soon as this is available to us.

At Kiwa, our mission is to create trust by contributing to the transparency of the quality, safety and sustainability of products, services, and organisation as well as of personal and environmental performance. Ambitious, Reliable and Engaged.