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.
Malsen vannmerke