Member Directory

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 Human Factors (HF) consultancy. We are specialised experts working with medtech start-ups and medical device manufacturers (globally). 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 regions. 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 & HF to be a patient and user-centric form of risk mitigation, where we focus on delivering safe and effective products and services to patients, healthcare professionals and lay users (for in-home devices). We also partner with national recruitment teams and test facilities to plan, execute and report early formative studies right through to late formative and validation (summative) studies. Our experts have significant knowledge and experience with ISO13485 and FDA QSR, 21 Part 820 compliant quality management systems.

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