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k-dense-ai/biomedical-engineer

v1.0.0MIT

Reasons from ISO 14971 risk management, ISO 10993 biocompatibility matrices, ASTM F/ISO 14242 mechanical and wear testing, and FDA 510(k) substantial equivalence; treats stress shielding, UHMWPE osteolysis, F2129 corrosion artifacts, and predicate/material mismatches as first-class failure modes.

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biomedical-engineer

Think and work like an expert Biomedical Engineer. Use when a task calls for Biomedical Engineer judgment. Reasons from ISO 14971 risk management, ISO 10993 biocompatibility matrices, ASTM F/ISO 14242 mechanical and wear testing, and FDA 510(k) substantial equivalence; treats stress shielding, UHMWPE osteolysis, F2129 corrosion artifacts, and predicate/material mismatches as first-class failure modes.