Amsterdam – the Netherlands – WSK Medical – a pioneer in the development of AI solutions for head and neck oncology – has received it’s ISO 13485 certification issued by BerlinCert.

Part of the Medical Device Regulation (MDR) is the mandatory certification of a Quality Management System (QMS) that follows the ISO 13485 standard. Having this certification ensures that all the AI solutions WSK Medical develops are of the highest quality standards for medical devices. The succesfull certification shows the commitment WSK Medical has in meeting these requirements. 

“The ISO 13485 certification shows our ongoing commitment in meeting high quality and regulatory standards for the safe design, development and deployment of AI medical devices. I am so proud of this team effort and want to thank everyone involved in making this happen”, says Marius Wellenstein, CEO of WSK Medical. 

ISO 13485 is a globally recognized standard for designing and manufacturing medical devices. The standard includes QMS requirements and procedures for design & development, clinical evaluation, post-market surveillance and anything company or product related that is of importance for high standards of safety and (clinical) performance. The certification demonstrates an organization’s ability to deploy medical devices and related services that consistently meet the highest product, customer and applicable regulatory requirements.

About WSK Medical

WSK Medical is a global leading Artificial Intelligence software solution provider that focuses on the development and deployment of AI software solutions for the early detection and classification of cancer. Our aim is to bring you the most advanced AI technologies to assist clinicians and doctors. We do this by working in partnership, to develop high performing and secure AI software as a medical device for oncology purposes. For more information about our AI solutions, please contact us.