Why Choose Maxis

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.


Pre Clinical

  • Engineering Lab
  • QMS System
  • Collaborative Research
  • Regulatory Assessment


  • USA
    • Break through next to 510k within the regulatory sections
  • Europe

Clinical Study

  • First In Human
  • Clinical Study Execution
  • CE Follow-up
  • Animal Lab
  • PMCF


  • Initial Sales Activites
  • Fundraising
  • Statistical Analysis/Data Science
  • Local Company Hosting EU & USA
  • Medical Writing


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


  • 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


  • 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

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

Let us help you!

We help develop your med tech startup from idea to market...