• Design control documentation
  • Implementation of quality training
  • Creation of FMEAs & risk analyses
  • Assistance in creation of design history files

  • 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

  • Planning and conducting international clinical studies
  • Analyzing clinical data
  • Developing clinical strategies
  • Management of workshops & advisory boards

  • 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 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.)

  • International project & program management
  • Product & project documentation
  • Life cycle management
  • Management and coordination of teams
  • International communication

  • 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

  • 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

  • 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

  • Experiences with leak tests
  • R&D Packaging support for Life Cycle Management projects:
  • Raw Material Specifications
  • Packaging Strategies
  • Packaging Transport Tests
  • Supplier communication

  • 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

  • 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

  • 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

  • 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