MAXIS is a medical device development company, focused on maximizing the preclinical, regulatory, clinical, and commercial success of emerging medical device technologies. MAXIS’ ability to design and execute customized strategies and clinical trials, paired with its commitment to providing comprehensive, long-term support, make us uniquely suited to start-up clients.

Clients can insource an exceptional senior team with comprehensive, multidisciplinary backgrounds, experience and proven track records that cannot be hired in one individual. Whether developing a strategy from the ground up, or troubleshooting and re-aligning a company’s pre-existing strategy, MAXIS’ vast and varied start-up experience enables us to create and adapt highly tailored, choreographed strategies. Options are thoroughly brainstormed, challenged and debated until consensus is achieved and aligned.

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, MDR & 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