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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
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Establish applicable user population and use environments.
Interactions​
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Evaluate product interactions with patients, HCPs, and caretakers.
Hazards​
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Identify hazards, prioritize, and mitigate according to ISO 14971.
Designs
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Optimize product design and reduce user errors.
Documents​
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Prepare risk plans, assessments, reports, and related documentation.
Improvements​
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Monitor post-market risk and adjust.
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