Medical Device Regulation
Comprehensive MDR compliance services ensuring your medical devices meet EU requirements for safety, performance, and clinical evidence.
Benefits of MDR Compliance
Patient Safety
Ensures medical devices meet EU safety and performance requirements.
Market Access
Legal requirement for selling medical devices in the EU.
Risk Management
Comprehensive risk management throughout device lifecycle.
Clinical Evidence
Robust clinical evaluation and post-market surveillance.
Key Features
Clinical Evaluation
Comprehensive clinical evaluation and evidence gathering.
Quality System
Implementation of ISO 13485-based quality system.
Risk Management
ISO 14971-compliant risk management system.
Post-Market Surveillance
Comprehensive post-market monitoring system.
Implementation Process
Classification
Determine medical device classification under MDR.
Technical Documentation
Prepare comprehensive technical documentation.
Quality Management
Implement quality management system (ISO 13485).
Clinical Evaluation
Conduct clinical evaluation and gather evidence.
Risk Management
Implement risk management system (ISO 14971).
Conformity Assessment
Complete conformity assessment with Notified Body.
Registration
Register in EUDAMED and maintain compliance.
Ready to Achieve MDR Compliance?
Let's discuss how we can help your organization meet EU Medical Device Regulation requirements.
Get Help With MDR Compliance
Let's discuss how we can help you implement the best practices and solutions for mdr compliance in your organization.