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Risk Management &
Design Control
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Risk Management process in accordance with ISO 14971
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Materials compliance: RoHS, REACH, Cal Prop 65, EU MDR
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Verification & Validation protocol and report
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Performance bench test
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Biocompatibility, Sterilization
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Safety, EMC, Transportation, Service Life, Shelf Life
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Preclinical, Clinical Studies
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RED: Wireless directive requirements
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Preclinical animals studies- study design, protocol & report
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