We are specialized in medical engineering.
Emphasis of knowledge covers the following points:

R&D Strategy & Leadership

  • R&D / F&E Project Management, strategic leadership & operation
  • R&D / F&E Marketing, Product Placement, Product claims, market entry strategy, markets and competition analysis,
    market and product launch and more.

    Regulatory Affairs

  • Regulatory requirements according to Medical Device Guidelines
  • Medical Device Directive (MDD / Directive 93/42/EEC)
  • Medical Device Directive (MDR / Council Directive 93/42/EEC)
  • MEDDEV 2.7.1, Rev 4
  • Regulatory Requirements according to U. S. Food and Drug Administration (FDA)
    – 510(k) Premarket Notification
    – Traditional 510(k), Special 510(k), Abbreviated 510(k)

  • Regulatory Requirements In-vitro Diagnostics according to VERORDNUNG (EU) 2017/746
  • Regulatory Compliance
  • Quality Management
  • Preparation Product Development Documentation and Technical Documentation according to MDR and FDA
  • Basic Knowledge about approval and registration of Medical Devices beyond the EAA
  • Strategic and operative experience in Pharmaceutical Industry (Project Leadership & Management)