As your legally designated EU representative, we serve as the crucial link between your organization and European authorities. Our comprehensive representation ensures continuous compliance while managing all essential communications and regulatory obligations within the EU market. We act as your local presence, handling time-sensitive matters and maintaining your regulatory standing.

• Official point of contact with EU authorities
• Regulatory compliance monitoring and updates
• Vigilance reporting and incident management
• Post-market surveillance coordination
• Document retention and maintenance
• Emergency response handling
• Competent authority communications
• Registration and notification management

Successfully navigating the CE marking process requires strategic planning and deep regulatory knowledge. We guide you through every step of product registration, ensuring your technical documentation meets all requirements while optimizing your path to market access. Our approach combines efficiency with thorough compliance to minimize delays and costs.

• CE marking pathway determination
• Product classification guidance
• Technical documentation review
• Clinical evaluation assessment
• Risk management review
• Declaration of Conformity support
• Labeling and IFU review
• EUDAMED registration assistance

Managing your presence in the European Database on Medical Devices demands precision and ongoing attention. We handle the complete lifecycle of your EUDAMED obligations, ensuring accurate data entry, timely updates, and proper maintenance of all required information while keeping you informed of important developments.

• Actor registration and validation
• Basic UDI-DI registration
• Device registration
• Certificate registration
• Clinical investigation registration
• Vigilance reporting
• Post-market surveillance reporting
• Periodic safety update reports

A robust technical file is the foundation of your product's compliance. Our systematic review process identifies potential gaps and opportunities for improvement, ensuring your documentation not only meets regulatory requirements but also effectively demonstrates your product's safety and performance.

• Gap analysis and assessment
• Technical documentation structure
• Essential requirements checklist
• Risk management file review
• Clinical evaluation report assessment
• Post-market surveillance planning
• Regular updates and maintenance
• Compliance verification

Choosing the right Notified Body is crucial for efficient certification. We analyze your specific needs and match them with the most suitable Notified Body, considering their expertise, timelines, and approach. Our established relationships with leading Notified Bodies help streamline the application and review process.

• Requirements assessment
• Notified Body evaluation
• Application preparation
• Technical documentation compilation
• Quality system assessment
• Communication facilitation
• Timeline management
• Process optimization

Drawing on our extensive experience in EU medical device regulations, we provide strategic guidance tailored to your specific needs. Our consultancy services help you navigate complex regulatory challenges while optimizing your resources and maintaining compliance throughout your product's lifecycle.

• Regulatory strategy development
• Quality management system design
• Risk management planning
• Clinical evaluation strategy
• Post-market surveillance planning
• Technical documentation preparation
• Compliance gap analysis
• Market access planning

Knowledge empowerment is essential for sustained compliance. Our training programs combine theoretical understanding with practical application, delivered by experienced regulatory professionals. We offer both standardized and customized training solutions to meet your team's specific needs.

• MDR/IVDR requirements
• Quality management systems
• Technical documentation preparation
• Clinical evaluation requirements
• Risk management principles
• Post-market surveillance
• Vigilance reporting
• Regulatory updates and changes