Your journey at a glance
Our services for MedTech companies
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Regulatory advice & approval
Development of individual approval strategies for the EU, USA and Asia. Complete technical documentation, conformity assessments and risk analyses in accordance with MDR/IVDR.
Clinical evaluation & studies
Preparation and maintenance of clinical evaluations according to MDR/IVDR. Planning, conducting and monitoring clinical studies – from protocol to data management.
Post-Market Surveillance
Establishment of effective PMS systems, creation of PSURs and vigilance activities. Continuous risk management based on post-market data.
Quality Management System
Development and implementation of a robust QMS in accordance with ISO 13485. Process optimization, document control and employee training. Mock audits to prepare for certification.
Training & education
Regulatory training for your teams on MDR/IVDR, clinical evaluation, PMS and quality management. Practical and tailored to your situation.
Interim & Project Management
Experienced experts as interim managers in regulatory affairs, clinical affairs or quality management. Efficient project management for development, approval and market launch.
International market access
Market access strategies for over 30 target markets. Adaptation to country-specific requirements, coordination of approval processes in the EU, CH, UK and USA.
Product monitoring & lifecycle
Systematic feedback loops for user feedback and product improvements. Lifecycle management to continuously adapt the product to market and regulatory changes.
