Monika KrasniqiConsultant and Project Manager

Monika is a specialist for design control of combination products and medical devices. She has gained experience during specific projects in university as a medical engineer in different fields, besides Biology and Physiology, also Regulatory Affairs, Quality Management (ISO 13585), Risk Management (ISO 14971) and Usability Engineering (ISO 62366).

Moreover, she is familiar with the overall design control process which includes conducting requirements engineering, design verification and design validation.

Expertise

  • Pre-Filled Syringe
  • Auto-Injectors
  • On-body devices
  • Combination Products
  • Regulatory Affairs
  • Risk Management 
  • Usability Engineering
  • Design Control
  • Technical Documentation
  • Change Control Management
  • Project Management Activities