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