Medical Devices Consulting
With more than 25 years of international experience in technology development, engineering leadership, and regulated product environments, I support medical device companies in developing safe, compliant, and commercially successful products.
My expertise combines deep technical know-how with hands-on experience in risk management, quality systems, design control, and innovation management across both medical devices and high-tech industries.
My Services
Risk Management for Medical Devices
- Preparation and review of Risk Management Files (RMF)
- Risk Management Plans (RMP) and Reports (RMR)
- Risk analysis using FMEA methodologies
- Risk management according to ISO 14971
- Usability and safety-related documentation
- Gap assessments and remediation support
Design Control & Product Development
- Setup and optimization of Design Control processes
- New Product Development Process (NPDP) implementation
- Design and development support from feasibility to market launch
- Technical documentation support according to MDR 2017/745 and IVDR 2017/746
- Development process reviews and compliance assessments
Quality Management & Regulatory Support
- Quality Management System (QMS) implementation and improvement
- Document Management System (DMS) setup
- Process definition and engineering governance
- Development-related compliance support
- Preparation and review of technical documentation
Training & Workshops
- Customized training for engineering and R&D teams
- Design Control training for medical device development
- Risk analysis and Design-FMEA workshops
- Practical implementation of ISO 14971 methodologies
- Cross-functional stakeholder training sessions
Innovation & Technology Consulting
- Technology and product roadmap development
- Competitive landscape and benchmarking analyses
- Innovation strategy support
- Intellectual property and patent-related assessments
- Evaluation and management of external development and manufacturing partners
Industry Experience
I have worked with international companies ranging from start-ups to global technology leaders in the fields of:
- Medical devices
- In-vitro diagnostics (IVD)
- Drug delivery systems
- Semiconductor and optoelectronic technologies
- Advanced manufacturing and packaging technologies
Recent consulting assignments include projects for companies such as:
- Boehringer Ingelheim
- Dentsply Sirona
- Sebia Orgentec
- SCHWIND eye-tech-solutions