Software Quality Assurance Services

We are a leading supplier of Software Quality Assurance and Regulatory Advice to industry and academia with many years’ experience in FDA, EMA, & MHRA regulated life sciences industries in the UK, Ireland, US, Far East and the EU. Our services include the following devices: Medical devices (and accessories), In-vitro diagnostic devices (and accessories), Wellness / lifestyle devices, Software as a medical device (SaMD) including mobile, web and cloud-based applications. We are the foremost provider of Software Quality Assurance to the emerging digital healthcare industry as a one stop solution to companies who seek to have medical devices that are solely/predominantly software through registration for CE Mark or FDA approval.