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. Read More

Regulatory Strategy - A detail plan and schedule to achieve a smooth path to clearance. Read More

Human Factors - Confirms user-friendly device design to comply with FDA usability standards. Read More

O P T I M I Z E

UI + UX Design - Focuses on optimizing the user experience considering clinical safety and efficacy. Read More

Industrial Design - Well crafted, ergonomic, visually compelling design that reflects your brand identity. Read More

Prototyping - Enables quick validation of human factors and overall usability. Read More

R E F I N E

Engineering - The creative application of scientific principles. Read More

User Feedback & Testing - Captures real world insights to improve performance and safety. Read More

Quality Assurance - Identifies and addresses risk early to deliver compliant medical devices. Read More

G U I D E

Regulatory Compliance - Guarantees FDA certification. Read More

Formative & Summative - FDA-required evaluations integrated throughout development (formative) to guide direction, and post-completion (summative) to confirm goals are met. Read More

510K Submissions - Strategic planning from the project start guarantees regulator success. Read More

E X E C U T E

CE, UL Certifications - Ensures compliance with international safety and quality standards. Read More

Manufacturing Optimization - Streamlining for cost-effective, scalable production. Read More

Post Market Surveillance - Monitors device performance, ensures continued compliance, and supports proactive risk management post launch. Read More