Discovery
We can help you explore unmet market needs, innovate with full consideration of commercial goals, and enhance the user experience.
Human factors research & design
Apply user-centered design principles through user research, adverse event analysis, usability testing, cognitive walkthroughs, staff training sessions, and more.
Regulatory strategy & gap analysis
Plan for rapid global market access with product classification, regulatory pathway selection, technical documentation, and quality management.
Software compliance & security
Use regulatory guidance on digital health, wireless compliance, software as medical device (SaMD), and security best practices to succeed with emerging technologies.
Clinical research
Assess clinical data requirements for your device and design a clinical strategy that supports your commercialization and product goals.
Risk management
Leverage design review, quality management, and clinical data to ensure product safety in line with ISO 14971 and ISO 14155.
Quality management system support
Implement and maintain a streamlined QMS in compliance with ISO 13485:2016 and local standards, with internal and gap audits to MDSAP requirements.
Technical file & dossier development
Get expert help compiling technical and design documentation tailored to requirements for European CE marking, US FDA 510(k) clearance, and access to global markets.
In-country representation
Employ local regulatory expertise to secure market access, conduct clinical trials, and maintain control of your medical device registrations.
Post-market compliance
Maintain your position on market with post-market clinical follow-up (PMCF), root cause analysis, incident reporting, and global vigilance support.
