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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.
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