Support of the development of safe and secure, attractive and easy to use products.

Description

We support the development of safe and secure, attractive and easy to use products. Our services for medical devices and IVD comply with: STANDARDS • IEC 62304:2006 • IEC 62366:2007 • IEC 62366-1:2015 • ISO 14971:2007 / EN ISO 14971:2012 • ISO 13485:2016 / EN ISO 13485:2012 • AAMI TIR 45 FDA GUIDANCES • General Principles of Software Validation • Content of Premarket Submissions for Software Contained in Medical Devices • Content of Premarket Submissions for Management of Cybersecurity in 
Medical Devices • Off-The-Shelf Software Use in Medical Devices • Applying Human Factors and Usability Engineering to Medical Devices