Our Services
Our services cover every stage of your medical device journey—from early concept to sustained market success. We integrate seamlessly with your team, bringing decades of regulatory, clinical, reimbursement, and commercialization expertise to help you move faster, minimize risk, and achieve measurable impact.
How We Help
• Prepare and submit 510(k), PMA, and De Novo applications.
• Determine the most efficient regulatory pathway.
• Ensure compliance with FDA, CMS, and international standards.
• Provide post-market support for ongoing compliance.
Regulatory Expertise – Fast-Track Your Path to Approval
We navigate FDA, CE Mark, and global requirements to accelerate approvals and minimize costly delays.
How We Help
Clinical Expertise – Turning Concepts into Validated Solutions
We design and manage trials that generate the evidence needed to prove safety, efficacy, and market readiness.
Develop trial protocols tailored to your device and patient population.
Select and manage trial sites that meet your specific needs.
Recruit patients efficiently using targeted outreach and networks.
Collect and analyze high-quality data for regulatory submissions.
How We Help
Reimbursement Strategy – Securing Market Access
We position your device for financial viability and widespread adoption by navigating payer requirements and building strong reimbursement pathways.
• Guide CMS Medicare and Medicaid reimbursement strategies.
• Secure appropriate billing codes and coverage determinations.
• Develop economic models that demonstrate value to payers.
• Build relationships with payers and providers to drive adoption.
How We Help
Commercialization – From Launch to Market Leadership
We create data-driven launch strategies that accelerate adoption, differentiate your product, and position it for sustained growth.
• Develop go-to-market strategies tailored to your target audience.
• Craft compelling brand messaging for stakeholders.
• Analyze competitive landscapes to identify opportunities.
• Build adoption programs for healthcare providers and systems.
How We Help
Lifecycle Support – Sustaining Long-Term Impact
We ensure your device remains competitive, compliant, and impactful well after launch.
• Monitor performance with post-market surveillance.
• Manage regulatory updates as requirements evolve.
• Identify opportunities for market expansion.
• Support product improvements based on feedback and performance.