Industries.
Medical technology consulting.
Customized solutions for Regulatory Affairs, Clinical Affairs, Quality Management and R&D.
Complex?
Vulnerable?
In a hurry?
Optimize your medical technology processes!
Customized consulting for the medical technology industry.
Medical technology companies face complex regulatory requirements, particularly in the area of MDR and IVDR compliance. At the same time, high standards in quality management and the efficient use of resources are crucial for success. We offer you comprehensive consulting services in the areas of regulatory affairs, quality management, clinical affairs and engineering in order to bring your products to market safely and efficiently
Our services cover all essential areas - from global market approval to process optimization. Whether you need support in implementing a quality management system (QMS) or assistance in carrying out clinical evaluations - we are your reliable partner in medical technology.
Comprehensive consulting services for medical technology.
Regulatory Affairs.
- Regulatory & Clinical Strategy
- Regulatory Compliance
- Global Market Access
- MDR/IVDR Readiness
- Person Responsible for Regulatory Compliance (PRRC)
- Technical Writing
Clinical Affairs.
- Clinical Evaluation Report (CER) / Clinical Investigations
- Performance Evaluation / Clinical Evidence IVD
- GCP & ISO 14155 / ISO 20916 Compliance
- Medical Writing
- CRO Support
- PMCF / PMPF
Quality Management.
- QMS Compliance and Implementation
- Process Optimization
- Process Verification & Validation
- Supplier Management
- Complaint Management & CAPA Support
- Inspection Readiness and Audits
- Post-Market Surveillance
R&D and Engineering.
- State-of-the-art assessments
- Design Control incl. Verification and Validation
- Risk Management
- Usability Engineering
- Biocompatibility
- Engineering
Our successes in medical technology consulting.
Challenge.
A medical technology company needed a scalable risk management system to meet MDR requirements and support future growth.
Measures.
- Introduction of a scalable risk management system that integrated design control and verification & validation processes.
- Development of strategies to optimize risk management processes.
Results.
- Successful implementation of a flexible system.
- Compliance with MDR requirements and support for future growth.
Success.
The company was able to future-proof its processes and comply with MDR requirements while being prepared for further growth.
