We are a dynamic team of experts for your device approval and quality matters. We have a diverse academic background and many years of practical experience in the life sciences.
Reinhard Köhler
Founder & GM, Consultant
Education
University Braunschweig, Diploma in Computer Science.
Core Competencies
- Over 20 years of corporate experience in medical product development, culminating in a three-year R&D Director role at Stryker CMF – leading 60 employees distributed around 3 sites in US, Ireland and Germany.
- Building high-performing teams/performance turnarounds
- Structuring, staffing, aligning & orchestrating medical device organizations.
- Medical device development, project management, quality management and regulatory affairs
- Quality Management (ISO 13485, ISO 14971, ISO 62304, MDR, CRF Part 820)
- Certified Professional for Medical Software (CPMS)
- Certificate: Quality Management Systems – TÜV Süd
- Certificate: Manager Regulatory Affairs – TU Lübeck
Working Skills
- Medical Imaging and Navigation Systems
- Coordination of offshore development partners
- Development of patient specific implants (class III)
- Medical device software development according to IEC 62304
- Computer System Validation (CSV)
- Software Verification and Validation
Dr. Thomas Wehner
Consultant
Education
PhD in Physics – Cologne University
Core Competencies
- Medical device software development according to IEC 62304
- Software Architecture, Verification & Validation
- Computer System Validation (CSV)
- Project Management
- Requirements Engineering
Working Skills
- Test Lead for FDA cleared ordering and tracking system for class III patient specific implants.
- Turnkey solution for MES to support design and manufacturing of class III patient-specific implants.
- Management of introduction of paperless electronic instructions for use system (eIFU).
- Model-driven implementation of pharmaceutical terminology management system.
- SCRUM product owner
- Roll-Out of a Continuous Integration System.
- Certified Project Manager (DIN 69900)
Techniques
- Domain Analysis
- Stakeholder View Modeling
- Agile Processes
- Process-Based Project Management
- Model-Centric Software Development
- User Story Testing
- Continuous Delivery
Paul Hiller
Consultant
Education
Diploma in Packaging Technology
M.Sc. Packaging, Design and Marketing
Core Competencies
- Packaging
- Design Control
- Cleaning, Disinfection and Sterilization
- Biocompatibility & Biological Risk Assessment
- Process Validations
- Clearance (CE and FDA)
Working Skills
- Design Transfer of Patient Specific Implants (class III)
- Transport Validation
- Supplier Audits
- Risk Assessment of Sterile Implants
- Cleaning Strategy for Implants
- Process Risk Analyses
- Transfer of sterile implants to the contract packager
- Implementation of new manufacturing processes for implants and instruments
Technologien
- Cleaning Technology
- Cleanroom Technology
- Packaging Technology
- Pressing and Crimping
- Machining Technology
- Stereo Lithography
- Surface Finishing
- Powder Coating