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)