Reduce complexity. Create clarity. Advance projects.
We support companies in complex and regulated environments – with analysis, structure, and pragmatic solutions that facilitate decisions and stabilize projects. In MedTech, we additionally support QMS and compliance topics.
Discuss Consulting ProjectReduce complexity. Create clarity. Advance projects.
We support companies in complex and regulated environments – with analysis, structure, and pragmatic solutions that facilitate decisions and stabilize projects. In MedTech, we additionally support QMS and compliance topics.
Discuss Consulting ProjectWhy Consulting?
Clarity
When structures become unclear
Focus
When teams have multiple construction sites simultaneously
Stability
When processes & responsibilities are unclear
MedTech Consulting
Precise, secure, practical.
We support manufacturers and organizations in the MedTech field with regulatory guidance, QMS structures, and implementation of MDR, FDA, and compliance requirements – without losing sight of the overall system.
- QMS setup and optimization (ISO 13485)
- Process design & SOP structure
- Guidance in MDR / FDA requirements
- Interface consulting between QA, RA, IT, and Production
- Preparation & support of internal & external audits according to DIN EN ISO 13485
Experience that counts
Over 15 years of expertise in quality management and regulatory affairs – with measurable results in the MedTech industry.
Auditor
Auditee
With 0 deviations
Our Services
Process Clarity
We create order in workflows, eliminate friction points, and define clear structures.
Decision Architecture
We develop priorities, responsibilities, and decision paths that relieve teams.
Structure & Implementation
We help teams organize projects and implement them pragmatically.
Quality & Compliance
We ensure clarity in QMS & compliance structures.
Our Approach
Analysis
Make problems visible
Structure
Reorganize systems & processes
Implementation
Implement pragmatic solutions
Sparring
Support & stabilize teams