We lead all project stakeholders through each step of our process to achieve remarkable outcomes.
F O S T E R
Market Research - Comprehensive market research to understand user needs.
Regulatory Strategy - A detail plan and schedule to achieve a smooth path to clearance.
Human Factors - Confirms user-friendly device design to comply with FDA usability standards.
O P T I M I Z E
UI + UX Design - Focuses on optimizing the user experience considering clinical safety and efficacy.
Industrial Design - Well crafted, ergonomic, visually compelling design that reflects your brand identity.
Prototyping - Enables quick validation of human factors and overall usability.
R E F I N E
Engineering - The creative application of scientific principles.
User Feedback & Testing - Captures real world insights to improve performance and safety.
Quality Assurance - Identifies and addresses risk early to deliver compliant medical devices.
G U I D E
Regulatory Compliance - Guarantees FDA certification.
Formative & Summative - FDA-required evaluations integrated throughout development (formative) to guide direction, and post-completion (summative) to confirm goals are met.
510K Submissions - Strategic planning from the project start guarantees regulator success.
E X E C U T E
CE, UL Certifications - Ensures compliance with international safety and quality standards.
Manufacturing Optimization - Streamlining for cost-effective, scalable production.
Post Market Surveillance - Monitors device performance, ensures continued compliance, and supports proactive risk management post launch.