Manchester, UK – DeepMed IO Ltd announced today that its quality management system (QMS) has been successfully certified as per ISO 13485:2016 requirements by HTCert Notified Body (2803) with scope “Design, development, production, technical assistance and installation of medical device software for precision medicine and digital/computational pathology”.
DeepMed IO Ltd ISO 13485:2016 certification serves to develop and implement an advanced QMS that can be thought of as a framework on which compliance to various regulatory and customer requirements have been built, internationally.
This achievement is aligned with the company’s quality objectives to design, develop and produce safe and efficient computer aided diagnostic systems as medical devices for supporting pathologists in diagnosis and treatment of diseases like cancer.
Dr. Konstantinos Vougas, founder and CEO of the company stated: “DeepMed IO invested heavily in getting the certification, since an effective and certified QMS is a hard-prerequisite for achieving CE-Marking and FDA-clearance of our products. Our next goal is the CE-Marking of our metastasis detection system for Lymph Nodes and immediate entry.”
Apart from all the DeepMed IO team that worked hard towards achieving this goal, we wish to thank our funder, the Small Business Research Initiative (SBRI – https://sbrihealthcare.co.uk/) and our trusted collaborators specialising in regulatory affairs, PKNM Solutions Sàrl (http://pknmsolutions.ch/).
About DeepMed IO
DeepMed IO is a MedTech company based in the UK. Our mission is to use AI to increase the accuracy and speed of diagnostic processes and deliver personalized care solutions for patients, thus prolonging their survival and improving their quality of life. Our exceptional team of experienced bioinformaticians and machine learning experts work hard around the clock to deliver AI tools with practical use in the clinic. To learn more visit https://www.deepmed.io/.