Offering EU IVDR support
Discover the new PEP and PER Smart Builders, and utilize the Product Classification service for IVDR kits.
Expert resources to plan your EU IVDR transition
The EU IVDR deadline is less than two years away. Visit our IVDR Resource Center for the latest resources, tools, and news from our regulatory and human factors experts.
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Discovery

We can help you explore unmet market needs, innovate with full consideration of commercial goals, and enhance the user experience.

Human 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.

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