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Design Control

Risk Management &

Design Control 

  • Risk Management process in accordance with ISO 14971

  • Materials compliance: RoHS, REACH, Cal Prop 65, EU MDR

  • Verification & Validation protocol and report

  • Performance bench test

  • Biocompatibility, Sterilization

  • Safety, EMC, Transportation, Service Life, Shelf Life

  • Preclinical, Clinical Studies

  • RED: Wireless directive requirements

  • Preclinical animals studies- study design, protocol & report

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