Service
Areas
Service Areas
Quality & regulatory
- PRRC
- Document control
- Regulatory advice strategy
- Build, certify & maintain
QMS according to ISO 13485
Business development
- Market analysis and development
- Supporting funding processes in a national and European context
- Management for hire
- Strategic support
Engineering
- Project Management
- Device, software, in vitro diagnostics
- Product engineering – from idea to serial production
- Risk Management
- Human factors engineering
- Design verification
Pharmaceutical systems
- IT
- Software testing
- Serialization
- Cybersecurity
- AI / ML systems
- GDPR
Vision
Be the partner of choice for companies operating in medical device, vitro diagnostics and the pharmaceuticalsectors.