Quality Engineering
- Design control documentation
- Implementation of quality training
- Creation of FMEAs & risk analyses
- Assistance in creation of design history files
Medical Affairs
- Scientific expertise
- Management of workshops & advisory boards
- Creation of design requirements from customer requirements
- Literature research
- Investigation of national & international standards
- Responding to medical inquiries
- Building and managing collaborations with external partners
- Creating and reviewing internal and external medical training documents
Clinical Affairs
- Planning and conducting international clinical studies
- Analyzing clinical data
- Developing clinical strategies
- Management of workshops & advisory boards
Research & Development
- Process development
- Product development
- Innovation methods
- Material testing
- Prototyping
- Test planning
- Electronics development
- Laboratory support & management
- Verification & validation
- Statistical analysis
- Support in the creation of design requirement matrices
- creation of material specifications
- Knowledge TÜV certified
Regulatory Affairs
- Regulatory advice for certification of medical devices
- Creation of regulatory strategies
- Preparation of technical documentation
- Review of technical documentation (MDD and MDR)
- Preparation and submission of regulatory documents in accordance with MDR and FDA requirements
- Advice for preparation of data for the European Database for Medical Devices (EUDAMED)
- TÜV certified knowledge about EUDAMED and FDA submissions (510(k), De Novo etc.)
Project Management
- International project & program management
- Product & project documentation
- Life cycle management
- Management and coordination of teams
- International communication
Quality Systems/Quality Operations
- Support of Change Management within an ISO 13485 qualified Quality Management System
- Audit Support
- CAPA Management
- Training Management
- Life Cycle Management of medical device documentation
- Support for the structure of Change Projects
- Update of Requirements Specifications
- Maintenance of incoming goods inspections
- Supplier Qualification
- Test Method validation
- Creating procedures
Facility Management
- Analysis of the current and future demand for spaces and infrastructures
- Creating requirement matrices
- Managing the entire Management Of Change (MOC)
- Detailed layout or facility planning
- Planning of construction or relocation phases, even during ongoing operations
Process validation
- Basics of process validation
- Validation planning
- Risk-based sampling plans based on RQL and AQL
- Documentation practices
- Change control and monitoring of validated processes
- Validation reports
- Knowledge TÜV certified
Packaging
- Experiences with leak tests
- R&D Packaging support for Life Cycle Management projects:
- Raw Material Specifications
- Packaging Strategies
- Packaging Transport Tests
- Supplier communication
Occupational Health Management
- Development of concepts for Occupational Health Management
- Kick-off workshop for the implementation of an OHM
- Employee survey
- Multi-day seminars on selected topics
- Risk assessment of psychological stress
- Ergonomics at the workplace
- Occupational addiction prevention
Leadership Culture
- Concept development for Healthy Leadership in your organization
- Vision, concept, and measures:
- Joint goal setting for healthy leadership
- Team workshops
- Leadership training
- Optimization as a continuous part of the organizational culture
Seminars and Lectures
- More time through meaningful delegation
- Stress management and time management for executives
- Change management: successfully accompanying change
- Fundamentals of communication
- Conflict management
- Stress management and resilience
- Healthy eating in the workplace
- Training to become an ergonomics coach
- Coaching on various topics
- Mediation
Other
- Learning management & training tools
- Newsletter & marketing material
- All-round back office work
- Strategy & team development
- Coaching
- Leadership Coaching by our external partner Ilka Fallgatter
- Management and coordination of teams
- Processing of databases (digitisation)
- Administrative support in the following areas (including in international groups):
- Procurement
- Travel organisation
- Event organisation