Kiwa Medical

Kiwa Medical offers Management System Certification – ISO 13485 and is in the process for UKCA Marking. We are also looking to add MDSAP to our portfolio as soon as this is available to us. EU MDR is currently available via our Global network ensuring that along with other Kiwa companies, our customers have access to key global markets. 

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 Medical, your partner for Compliance

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Discover our services

  • ISO 13485 Medical Devices

    ISO 13485 Medical Devices Certification with Kiwa: ensure quality, build trust and comply with regulations in the medical devices sector.
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  • CE Marking of Medical Devices in accordance with MDR

    Medical devices manufactured or traded in the EU must comply with the Medical Device Regulation (EU) 2017/745 (MDR) and must be CE marked. Kiwa Cermet Italia and Kiwa Dare (based in The Netherlands) have been designated notified body for Regulation (EU) 2017/745 (MDR).
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