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WHY CHOOSE MAXIS

MAXIS Medical is a clinical market development company focused exclusively on emerging medical technologies. MAXIS is experienced in strategic consulting, clinical research, regulatory affairs and market development— providing a full range of services for start-up medical device companies and complete ‘wrap-around’ support for early stage needs.


MAXIS Medical services include:


Pre-Clinical

  • Device development, validation & animal studies
  • R&D for design freeze & regulatory documentation
  • Risk/benefit & statistical expertise in trial design
  • Technical Dossiers & Investigator Brochure development
  • Investigator site selection & qualification

Clinical

  • FIH, pre-CE Mark, IDE, Pivotal and Post-market study design and implementation
  • Customized EDC development, site management & field case support
  • CRO data collection, monitoring, analyses & DSMB/CEC management
  • Creation & implementation of clinical training programs
  • Troubleshooting, fixing & pivoting clinical programs
  • Investigator ´study group´ meetings, publication strategies & podium presence

Regulatory

  • Protocol development & regulatory strategy
  • EC/IRB, IDE, Competent Authority, 510k, PMA & CE Mark submissions
  • GCP and related training for target investigators & research staff
  • Quality systems design, regulatory compliance & audits
  • European Authorized Representation (EAR)

Market Development

  • Market research with KOL access
  • Development & implementation of reimbursement strategies
  • Due diligence for strategic valuations
  • Inventory storage & management for clinical trials/post-market programs
  • Organizing congresses, newsletters and events