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• User Research – Physicians, Nursing Staff, Patients,
Administrators and demands of clinical environments
• Design and documentation to satisfy Regulatory
requirements – FDA, IEC, CE, ISO, Risk Management etc.
• Knowledge of medical technologies and medically
suitable materials and processes
• Human Factors, User Interaction Design, Risk
Assessment referencing CDRH consensus standards,
FMEA process and ISO 14971
• Medical packaging design – materials and sterility issues,
labeling requirements
• Design and development for Prototype and Pilot Production to
meet clinical testing and Validation needs – 510(k) and PMA paths
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