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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  • ISO 13485:2016 is the medical device industry's quality management system (QMS) standard. The scheme specifies the requirements for a quality management system for medical devices.
  • Medical Devices are an heterogeneous category of products, such as active equipment, orthopaedic implants, reusable instruments, substances and materials, software, and more. These devices, designed for medical purposes and intended for use in or on humans, achieve their primary effects through mechanisms other than pharmacological, immunological, or metabolic actions. Before entering the European Economic Area (EEA) market, the medical devices need to be compliant to applicable legislation and obtain the CE marking.