Sento Solutions Pty Ltd
Website: https://sentosolutions.com.au/
Member Contact: Carla Zampaglione
Position: Director
Industry: Industry Support Services
Company Profile:
Sento Solutions (Sento) are a Usability Engineering (UE) and User Experience (UX) consultancy. We are specialised experts working closely with medtech start-ups and medical device manufacturers (globally) to support medical device R&D programs. Sento comply with all human factors and usability engineering standards and guidances to support Class I, II and III regulatory submissions across US, EU and AU. We conduct early user research to identify user and patient needs, right through to detailed use-related risks analysis and summative studies. Sento consider UE & UX to be a patient and user-centric form of risk mitigation, where we focus on helping to deliver safe and effective products and services to patients, healthcare professionals and lay users (for in-home devices). We also partner with both Australian and US participant recruitment teams and test facilities to plan, execute and report early formative usability studies right through to late formative and validation (summative) studies. Our experts have deep knowledge and experience in the product development process and commercialisation, and are very familiar with ISO13485 and FDA QSR, 21 Part 820 compliant quality management systems and frameworks.
