Our Approach

Whether you are in the Biotech Medtech or Diagnostic industry, our extensive team provides a world-class service. Our consultants take a risk-based approach to improve quality & compliance and they implement practical solutions for your organisation (from start-up to large companies).

Quality Assurance

Quality management system (QMS) development & implementationISO9001
• EU/UK QP&RP Services
• Remediation Support & Management
Deviation & CAPA Management and Improvement
Quality Documentation (SOP, Protocols, Reports, Simplified KPI Generation, etc.)
• Risk Assessment
• Root Cause Investigations

Quality Assurance

Quality management system (QMS) development & implementationISO13485
Design Verification & Validation
• Post-production Compliance
• Project Management
• Risk Management
• Process Validation
Unique Device Identification (UDI)
• Virtual Document Control

Do you already have a project in mind?