FEATURED SERVICE
Create your IVDR Technical Documentation faster
The newest RAMS Smart Builder walks you through the IVDR Technical Documentation File so you can save time and minimize errors that delay regulatory approval.
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FEATURED RESOURCE
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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MDR Resource Center
MDR Resource Center
The knowledge you need for MDR implementation
The knowledge you need for MDR implementation
Europe's Medical Devices Regulation (MDR) goes into effect in May 2021, and we want you to be prepared. Meet our MDR team and get free educational resources on the MDR.
Our Services
Our experienced staff and global network will provide the support you need.
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.
Pharmaceuticals / BioTech
The demand for combination products continues to grow. We partner with combination product developers to overcome regulatory challenges as well as design safer, more effective products that help deliver more personalized and precise care.
