A User Focused Process drives our Comprehensive Medical Device Development Services.
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
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