Medical Device Product Development

Kymanox gives you peace of mind by providing technical experience to make your product a success

Design, Development, & Testing

  • • Product & Device Development
  • • Design Control & Risk Management
  • • Human Factors Engineering
  • • Design & Innovation Services
  • • Process Development
  • • Test Engineering
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    Quality & Compliance

  • • Quality Assurance
  • • Audit/PAI Readiness
  • • Clinical & Medical
  • • Post Market Surveillance
  • • Complaint Management
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    Facilities & Manufacturing

  • • Automation
  • • Facility/Utility Engineering
  • • Validation(CQV)
  • • ERP & Computer System Validation (CSV)
  • • Packaging Technology & Engineering
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    Technical Operations

  • • CMC
  • • Process Engineering
  • • Microbiology & Analytical Sciences
  • • MS&T
  • • Supply Chain & Logistics
  • • Tech Transfer
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    Regulatory Affairs

  • •Advisory Services
  • •Regulatory Submissions
  • •Regulatory Body Interactions
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    Executive Support & Strategy

  • •Program & Project Management
  • •Executive Advisors (KEA)
  • •Due Diligence
  • •Staffing
  • •Hyper-Virtual Model
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    Life Science Products & Services Where We Excel

    Medical Devices

    Medical Devices

      • Class I/II/III
      • Software as a Medical Device
      • Surgical Devices
      • In Vitro Diagnostics

    Tissue & Organ

    Tissue & Organ

      • Regenerative Medicine
      • Stem Cell

    Contract Development & Manufacturing Organizations (CDMO)

    CDMO

      • Evaluation & Selection
      • Management
      • Tech Transfer