Risk Management & Usability

Suma Medtec integrates risk management and user considerations into the product development cycle to reveal effective mitigations and design improvements at the opportune time.

Users: Establish applicable user population and use environments.

Interactions: Evaluate product interactions with patients, HCPs, and caretakers.

Hazards: Identify hazards, prioritize, and mitigate according to ISO 14971.

Designs: Optimize product design and reduce user errors.

Documents: Prepare risk plans, assessments, reports, and related documentation.

Improvements: Monitor post-market risk and adjust.